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Studies
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New Programs(25 Records found)
CTO#: 101928
Brain and Nervous System, Breast-Female, Colon, Lung
Status: Active/Enrolling
Sponsor: NIH/NIDA (101928)
A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
Lay Description:
No Documents currently available
...details...
CTO#: 101914
Status: Active/Enrolling
Sponsor: RTOG (1205)
Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
Lay Description: This study is for patients that have a brain tumor, called a glioblastoma or gliosarcoma, which has become worse after previous treatment. The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastomas.
In this trial patients will be randomly assigned to receive either bevacizumab alone or bevacizumab and radiation therapy.If you are in Group 1, you will be asked to take bevacizumab alone every two weeks as long as it is working and there are no intolerable side effects. If patients are assigned to Group 2, he/she will take bevacizumab 2 weeks before radiation therapy, during radiation therapy, and then every 2 weeks after radiation therapy as long as it is working and there are no intolerable side effects. The radiation will be given to participants over 2 weeks. Participants will be followed every 8 weeks while on treatment and then also if participants are removed from protocol treatment. Follow-up will continue every 8 weeks for 1 year, then every 6 months for 1 year, then annually.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101909
Status: Active/Enrolling
Sponsor: MUSC ()
Valproic Acid for Children with Recurrent and Progressive Brain Tumors
Lay Description:
No Documents currently available
...details...
CTO#: 101904
Status: Active/Enrolling
Sponsor: CALGB (80702)
A PHASE III TRIAL OF 6 VERSUS 12 TREATMENTS OF ADJUVANT FOLFOX PLUS CELECOXIB OR PLACEBO FOR PATIENTS WITH RESECTED STAGE III COLON CANCER
Lay Description: This study is for subjects who have cancer of the colon, which has been surgically removed, but has spread to lymph nodes. This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat this type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX”. The Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
In this study, researchers will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. Celecoxib is approved by the FDA to treat arthritis and some other painful conditions. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving subjects celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence.
This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care is 12 treatments with FOLFOX. In this trial, researchers will explore whether 6 treatments are as effective as 12 treatments and whether side effects can be reduced with fewer treatments. It expected that subjects will be enrolled in this trial for up to 3 years.
Diet and Lifestyle Questionnaire
HIPAA
Informed Consent
Working Protocol
...details...
CTO#: 101894
Melanoma, skin, Other Skin
Status: Active/Enrolling
Sponsor: MUSC ()
Bioactive Sphingolipids in Circulating Exosomes in Relation to the NMSC Cancer-prone Phenotype (SCAN Study)
Lay Description:
No Documents currently available
...details...
CTO#: 101874
Breast-Female
Status: Active/Enrolling
Sponsor: RTOG (1119)
Phase II Randomized Study of Whole Brain Radiotherapy in Combination With Concurrent Lapatinib in Patients With Brain Metastastis From HER2-Positive Breast Cancer a Collaborative Study of RTOG and KROG
Lay Description: This study is for patients with HER2-positive breast cancer that has spread to the brain. The purpose of this study is to compare the effects of adding lapatinib to standard whole brain radiation therapy (WBRT) on the patient and the patient’s cancer. Patients on this study will receive either lapatinib plus WBRT or WBRT alone. It is expected that patients will be on this study for 3 weeks. Patients in Arm B, will continue taking lapatinib for 3 more weeks after finishing WBRT. After patients have finished receiving treatment on either Arm A or Arm B, the study doctor will ask patients to visit the office for follow-up exams every 12 weeks for the rest of their life.
Consent
HIPAA
Protocol
...details...
CTO#: 101870
Status: Active/Enrolling
Sponsor: COG (ANHL1131)
ANHL1131: Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma NHL or Mature B-cell Leukemia B- AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients.
Lay Description:
No Documents currently available
...details...
CTO#: 101864
Status: Active/Enrolling
Sponsor: Genentech (ML28257)
An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with HER2 Positive Metatastic Breast Cancer
Lay Description: This study is for subjects who have been diagnosed with HER2+metastatic breast cancer. This is an observational study and will follow the regular medical care and treatments given to subjects who have been diagnosed with HER2+ metastatic breast cancer. Subjects will not be asked to take an experimental drug or participate in any experimental procedures. The main purpose of this study is to collect information on how subjects who have metastatic breast cancer are treated, and how they respond to the various treatments for this disease. Because this is an observational study, your doctor will determine the best treatment for you.
After enrollment, each subject's doctor will provide information about the history of their metastatic breast cancer, results of tests done for their cancer, and past treatments they have received. Four times per year (every 3 months), each subject's doctor will provide Genentech with information about their ongoing breast cancer treatment, results of tests performed, response(s) to treatment, and any complications experienced. Subjects' doctors will continue to provide this information four times per year for 5 to 8 years from the time subjects are enrolled in this study.
To understand how subjects are feeling, they will be asked to complete several questionnaires at baseline and periodically throughout study participation, during site visits and remotely, to assess overall health status, activities of daily living, and if they have had any other health issues. Subjects will be enrolled in this study for 8 years. Also, depending on when subjects are enrolled during the 36 month enrollment period, subjects will be followed for 5 to 8 years.
HIPAA
Informed Consent
Patient Materials FACT-B Document
Patient Materials General QOL Document
Patient Materials Health Care Survey
Patient Materials MDASI MUSC
Patient Materials PNQ_A2
Patient Materials PROCTCAE
Patient Materials RSCL
Patient Materials WPAI
Patient Materials-AlopeciaPA Document
Working Protocol
...details...
CTO#: 101862
Status: Active/Enrolling
Sponsor: Novartis (CLDE225A2112)
A Phase Ib, Multi-center, Two Parallel Group, Open-label, Drug-drug Interaction Study to Assess the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients with Advanced Solid Tumors
Lay Description: Subjects are being asked to participate in this study to find out if the drug LDE225 is safe and has beneficial effects in people who have advanced solid tumors.
When subjects decide to participate, they will be asked to come to the study site to see if they are eligible to participate in the study (1-3 hour visit). If they are eligible for the study, they may be asked to come to the study site for an overnight stay, and then return every 24 hours for the next 6 days (1 hour visits). On the 6th day, they will begin the first of 6 (or more if you continue to have benefit from the drug) cycles that will last 28 days. During the first cycle you will return on days 8, 15 and 22. During Cycle 2, subjects may repeat the overnight stay at Day 21 to 23. They will then return once a day for the next 5 days. During Cycle 3, subjects will have 2 visits on day 1 and 15. Starting at cycle 4 and for the rest of the cycles they will have 2 visits on day 1 and 28. After a subject completes treatment, they will have an End of Treatment visit, followed by a safety follow up visit 30 days later.
Subjects will be asked to come to the doctor’s clinic 35 times over about 220 days. Each visit should take about 1 to 2 hours. If subjects continue to benefit from the study drug, they may continue your treatment with visits on day 1, 15 and 28 of each 28 day cycle.
Consent
HIPAA
Protocol
...details...
CTO#: 101860
Status: Active/Enrolling
Sponsor: Celgene (CC-122-ST-001)
A Phase 1A/1B, Multi-Center, Open-Label, Dose Finding Study to Assess The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of The Pleiotropic Pathway Modifier CC-122 Administered Orally To Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma Or Multiple Myeloma
Lay Description: This study is for subjects that have cancer that has spread or that cannot be cured by surgery, drugs, or any other known treatments. The main purpose of this study is to test the safety of a new experimental drug called CC-122, a Pleiotropic Pathway Modulator (PPM). Pleiotropy refers to a case where one gene may influence several other characteristics or may have multiple effects in numerous tissues. CC-122 belongs to a new class of drugs called “PPMs.” These drugs affect how the immune system works, slow the growth of tumor cells and block blood vessel growth in tumors. Approximately 100 people will take part in this study. The goal of this study is to test the highest, and/or the near-highest tolerated dose level. It may be necessary to test more than one dose level. This study will take place in the United States and in countries in Europe. This study will take about 18 to 24 months to complete. This study is only open to certain types of cancer including: (1) locally advanced (including inflammatory) breast cancer (LABC), (2) hepatocellular carcinoma (HCC), (3) certain types of brain tumor called glioblastoma multiforme (GBM), (4) multiple myeloma (MM), and (5) diffuse large B-cell lymphoma (DLBCL).
Consent
HIPAA
Patient Diary
Protocol
...details...
CTO#: 101854
Status: Active/Enrolling
Sponsor: GOG (3003)
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF VTX-2337 (IND #78,416) IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN PATIENTS WITH RECURRENT OR PERSISTENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER
Lay Description: This study is for subjects with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after treatment or did not respond to earlier treatment. The purpose of this study is to compare pegylated liposomal doxorubicin (PLD; a standard chemotherapy) to PLD in combination with VTX-2337 (a new type of drug that stimulates the immune system) to see if it helps cancer tumors stop growing or shrink, and if it helps women with these types of cancer live longer. PLD is an FDA-approved treatment for women with ovarian cancer. In prior studies, approximately 15–20% of women who received PLD for relapsed ovarian cancer experienced a temporary shrinkage or disappearance of their tumor. VTX 2337 is an experimental drug (not approved by the Food and Drug Administration, FDA) that stimulates the immune system and may help the body kill cancer cells. The combination of PLD plus VTX-2337 has been evaluated in a previous study of 13 patients. The study is still ongoing, but so far there is evidence that PLD + VTX-2337 may temporarily stop some patients’ tumors from growing (this happened in 6 patients), or it may help cancer tumors temporarily shrink and/or disappear (this happened in 1 patient).
In addition to the treatment part of this study, the researchers plan to test samples of your tumor and some of your blood. You cannot participate in this study if you do not agree to provide these specimens for this research. The purpose of this research is to examine the impact the study drugs have on tumor tissue and specific blood cells and substances.
Lastly, researchers want to know if one's genes (DNA) affect how the body responds to the experimental medication or how one's body breaks it down. Subjects will receive the study drugs as long as there is evidence that their tumor is not growing and they are not experiencing unacceptable side effects.
Consent
HIPAA
Protocol
...details...
CTO#: 101853
Ovary
Status: Active/Enrolling
Sponsor: GOG (0212)
A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or CT 2103 (IND# 70177) Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
Lay Description: This study is for patients that ovarian, primary peritoneal or fallopian tube cancer that has been confirmed by surgery. This study will examine whether women with advanced ovarian, primary peritoneal or fallopian tube cancer who have no evidence of disease after the completion of initial chemotherapy live longer if a specific treatment program is continued once a month for 12 months versus stopping all chemotherapy until there is evidence of recurrence of the disease process. Two different chemotherapy regimens and one regimen including no further treatment will be examined. The first of the chemotherapy arms, paclitaxel, is a standard chemotherapy drug used to treat ovarian cancer, and was the agent utilized in the trial noted above. The second agent, CT-2103, is an experimental drug with anti-cancer activity similar to that of paclitaxel. It is possible that CT-2103 will produce similar results to that achieved with paclitaxel, but with reduced side effects. Patients will be randomly assigned to receive one of the two treatments. The treatments will be continued for a maximum of 12 months depending on how well patients respond to treatment and the seriousness of any side effects. The study doctors will follow patients' medical condition by office visits every three months for two years and then every six months for three more years.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101848
Brain and Nervous System
Status: Active/Enrolling
Sponsor: NCCTG (N107C)
A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease.
Lay Description: This study is for patients with cancer somewhere else in the body that has metastasized (spread) to the brain. The purpose of this study is to compare overall survival and to compare the effects (good and bad) of stereotactic radiosurgery (SRS) to whole brain radiation therapy (WBRT) on the patient and the brain metastases. Patients on this study will receive either (Group A) whole brain radiation therapy (WBRT) or (Group B) stereotactic radiosurgery (SRS). It is expected that patients will be on this study for as long as they are alive or for a maximum of five years after they begin this study to look for any long-term effects of the treatment in this study.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101847
Breast-Female
Status: Active/Enrolling
Sponsor: ACOSOG (11102)
Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC)
Lay Description: This study is for patients with Multiple Ipsilateral Breast Cancers (MIBC). The purpose of this study is to see if removing only the tissues from the 2 or 3 cancers in the breast (breast conservation surgery) in combination with radiation to the breast, instead of removing the entire breast (mastectomy) is safe in keeping the cancer from coming back in the breast. After surgery, patients on this study will receive either hormone treatment or chemotherapy. Patients will also receive Whole Breast Irradiation (WBI). It is expected that patients will be on this study for up to 5 years after the WBI is completed.
HIPAA
Informed Consent
Patient brochure
Protocol
...details...
CTO#: 101846
Kidney
Status: Active/Enrolling
Sponsor: Hoosier Oncology Group (QL12-153)
Phase II Study of Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Patients with Germ Cell Tumors Undergoing 5 Day Cisplatin Based Chemotherapy
Lay Description: This study is for patients with germ cell cancer that are receiving standard treatment with a 5-day Cisplatin-based chemotherapy. The purpose of this study is to determine if EMEND, also known as fosaprepitant, (a drug used for the prevention of nausea [upset stomach] and vomiting caused by chemotherapy) can reduce sudden and delayed symptoms of nausea and vomiting. Patients on this study will receive 150mg EMEND by IV (injected into a vein in the arm) over 20-30 minutes and approximately 30 minutes before the chemotherapy dose on Day 3 and Day 5. It is expected that patients will be on this study for up to one month after the last dose of the study treatment.
Consent
HIPAA
Patient Logs
Protocol
...details...
CTO#: 101840
Prostate
Status: Active/Enrolling
Sponsor: Veterans Affairs ()
Vitamin D3 Supplementation for Low-Risk Prostate Cancer, a Randomized Trial
Lay Description:
No Documents currently available
...details...
CTO#: 101839
Kidney, Other Male Genital, Other Urinary, Prostate
Status: Active/Enrolling
Sponsor: MUSC ()
Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients with Advanced Cancer
Lay Description: This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer. The term "phytochemicals" refers to a wide variety of compounds produced by plants. They are found in fruits, vegetables, beans, grains, and other plants. This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract. Subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes) will receive grape seed extract alone once or twice a day for 21 days. Then subjects will begin taking Vitamin D-3 at a fixed dose for 42 days. It is anticipated that this study may last approximately 65 days.
FACT-P Questionnaire
HIPAA
Informed Consent
Patient Diary_COHORT 1_D1-21
Patient Diary_COHORT 1_D22-63
Patient Diary_COHORT 2-4_D1-21
Patient Diary_COHORT 2-4_D22-63
Protocol
...details...
CTO#: 101838
Melanoma, skin
Status: Active/Enrolling
Sponsor: MUSC ()
A Feasibility and Safety Study of Vaccination with Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients with Metastatic and/or Unresectable Melanoma
Lay Description: This study is for patients with a type of skin cancer called melanoma. The purpose of this study is to examine the safety of the study drug in patients with the disease. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for the disease. Patients on this study will have a procedure called leukapheresis. Leukapheresis is a process in which the patient will have white blood cells collected from their body. The total amount of plasma and white blood cells collected will be about one pint. These cells will be given together with Poly-ICLC therapy when the patient begins study treatment. Some days the patient will receive both Poly-ICLC and dendritic cells, but on other days the patient will receive the Poly-ICLC by itself. It is expected that patients will be on this study for approximately 35 to 49 days (up to 7 weeks). The study treatment phase will last approximately 56 days (8 weeks). Afterwards, the patients study doctor may elect to follow the patient at regular intervals as described above.
consent
HIPAA
protocol
...details...
CTO#: 101837
Ovary
Status: Active/Enrolling
Sponsor: MUSC ()
Using Serum HE4 and CA125 to Monitor the Therapeutic Effects in Ovarian Cancer Patients Based on Histological Subtypes
Lay Description: This study is for patients with ovarian cancer. The purpose of this study is to investigate HE4 and CA125 expressions in different types of ovarian cancer and to evaluate the changes in HE4 and CA125 before and after treatment. Eligible patients on this study will have their blood drawn and approximately 5mL or 1 teaspoon will be taken before and after surgery to evaluate HE4 and CA125 expressions. It is expected that patients will be on this study for one year.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101835
Myeloid and Monocytic Leukemia
Status: Active/Enrolling
Sponsor: Celator (CLTR0310-301)
Phase III, Multicenter, Randomized, Trial of CPX-351 (CYTARABINE:DAUNORUBICIN) Lipsome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age with Untreated High Risk (Secondary) AML
Lay Description: This study is for patients 60-75 years old who have been diagnosed with high risk (secondary) leukemia and have not received any treatment for the disease. CPX-351 is the study drug that will be used and it is a formulation of a fixed combination of the two anti-tumor drugs, Cytarabine and Daunorubicin. This study will use what is called a “liposome” injection. This is a special fat capsule (called a liposome) that surrounds the Cytarabine and Daunorubicin and protects the drugs from being eliminated/ destroyed by the body. This study drug formulation is experimental. Throughout this study, we plan to learn how safe CPX-351 is and how effective it is on this disease. In this study, patients may be treated with up to 2 cycles of treatment (either the study drug or the current standard of care, which is a combo of drugs, Cytarabine and Daunorubicin) that will hopefully control the disease and cause remission. Patients could receive medication for 1 to 5 months depending on how they respond to treatment as well as the side effects. Once they stop treatment, their condition will be followed at monthly intervals (once a month) by their doctor for 1 year from the date they started the study. After the first year, they will be followed for up to 5 years from the date they started the study.
Consent
HIPAA
Protocol
...details...
CTO#: 101832
Other Urinary
Status: Active/Enrolling
Sponsor: Hoosier Oncology Group (GU10-147)
Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma
Lay Description: This study is for patients with transitional cell carcinoma. The purpose of this study is to see the safety and effectiveness of Everolimus when given alone or when given in combination with Paclitaxel. Patients on this study will receive either Everolimus alone or Everolimus along with Paclitaxel. It is expected that patients will be on this study until unacceptable toxicities, disease progression, or Physician’s decision to withdraw the patient from study.
Consent
Drug Diary
HIPAA
Protocol
...details...
CTO#: 101827
Brain and Nervous System
Status: Active/Enrolling
Sponsor: NMTRC (NMTRC 003)
A Phase II Preventative Trial of DFMO (eflornithine HCl) as a Single Agent in Patients with High Risk Neuroblastoma in Remission
Lay Description:
No Documents currently available
...details...
CTO#: 101826
Pancreas
Status: Active/Enrolling
Sponsor: MUSC (101826)
Phase II Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients with Localized, Resectable, Adenocarcinoma of the Pancreas
Lay Description: This study is for patients with adenocarcinoma (cancer) of the pancreas. The purpose of this study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Patients on this study will receive Gemcitabine and Abraxane by IV (intravenously or by a needle in the vein) on days 1 and 15 of each cycle. Each cycle of treatment will be 28 days. Patients may have up to 3 chemotherapy treatment cycles and will be seen by the doctor every two weeks prior to each administration of chemotherapy. Within 4 to 8 weeks after patients have completed chemotherapy treatment, patients will complete the following evaluations to determine the status of the disease and if they can proceed to surgery. It is expected that patients will be on this study for 12 to 15 weeks. Each treatment cycle for this study lasts 28 days. Patietnts may have up to 3 treatment cycles. If eligible, patients will have surgery within 4 to 8 weeks following the completion of chemotherapy treatment.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101825
Prostate
Status: Active/Enrolling
Sponsor: RTOG (1115)
Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GnRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GnRH Agonist and
TAK-700 for Men with High Risk Prostate Cancer
Lay Description: This study is for patients that have prostate cancer. The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and TAK-700 plus radiation therapy with hormone therapy (androgen deprivation) and radiation therapy on patients and their prostate cancer to find out which is better. TAK-700 is a new drug that is experimental, which means that this drug is not approved by the United States Food and Drug Administration (FDA). TAK-700 is a pill intended to further reduce the levels of testosterone and other male hormones that may also cause continued growth of the prostate cancer. There are 2 treatment groups in this study:
1)Patients who receive hormone therapy plus radiation therapy only
2)Patients who receive hormone therapy and TAK-700 plus radiation therapy
Participants assigned to Group 1 will receive radiation treatments to the whole pelvis once daily, 5 days a week, for a total of 25 treatments. Participants assigned to group 2 will receive radiation treatments to the whole pelvis once daily, 5 days a week,for a total of 25 treatments. Group 2 will also take TAK-700 by mouth (pill) two times a day for 24 months. Both groups will receive hormone therapy for 24 months. After therapy, follow-up exams will occur every 6 months for 3 years and then once a year. Participants will be asked to update the study doctor on their medical condition every year for their lifetime.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101824
Kidney
Status: Active/Enrolling
Sponsor: Argos (AGS-003-007)
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS 003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Lay Description: This study is for subjects with newly diagnosed advanced kidney cancer who have previously consented to allow for collection of a tumor sample, which may be used to make a personalized experimental drug called AGS-003. Argos Therapeutics is sponsoring this research study using their experimental (investigational) drug AGS-003 to see if it is effective against kidney cancer. An investigational drug is a medication that is still being studied and has not been approved for use in the general population by the United States Food and Drug Administration (FDA). AGS-003 is made for subjects by using a piece of tumor collected after surgical removal of their kidneys along with a certain type of their own white blood cells. The resulting product is a type of immune cell called a dendritic cell, which is very good at activating the immune system against cancer cells.
AGS-003 can be used in combination with the approved, regular medications most often prescribed for the treatment of kidney cancer. In this study, one group of subjects will receive regular medications for kidney cancer and a second group will receive regular medications for kidney cancer plus AGS-003. An important purpose of this study is to see if treatment with AGS-003 plus regular medications is any different than treatment with regular medications alone. Subjects are expected to be enrolled in this study for approximately 3 years.
HIPAA
Informed Consent
Patient Card
Protocol
Tissue consent
Tissue HIPAA
...details...
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