Part 2 of Phase 1 Study of GC1008 to Treat Advanced Melanoma (Part 2 Will Only Accept and Treat Patients With Advanced Malignant Melanoma)
- GC1008 is a genetically engineered antibody designed to block the activity of transforming growth factor-beta (TGF-beta). Although TGF-beta has some normal and beneficial effects in the body, it is often over-produced in malignant melanoma tumors, and it can help the melanoma grow and spread.
- Part 1 of this study enrolled 22 subjects with malignant melanoma or kidney cancer to determine the highest safe dose of GC1008, which was found to be 15 mg/kg.
- Three of 22 patients with malignant melanoma in Part 1 of the study developed skin problems, but it is not known if these problems were related to the administration of GC1008.
-To determine the frequency of adverse skin side effects of GC1008 in patients with malignant melanoma.
-Patients 18 years of age and older with malignant melanoma for whom previous treatment was not successful.
- GC1008 is given intravenously (through a vein) at a dose of 15 mg/kg or 10 mg/kg for four doses on study days 0, 28, 42 and 56 (one treatment cycle). Patients whose cancer responds to GC1008 may receive one or two additional treatment cycles of four doses given every two weeks.
- Physical exam and vital signs on study days 1, 14, 28, 42, 56, 84 and 140.
- Vitals signs on study days 0, 14, 28, 42, 56, 84 and 140.
- Frequent blood sample collections for routine safety tests, measurement of blood levels of GC1008, analysis for antibodies against GC1008 and for research studies.
- CT or MRI scan, bone scan and PET CT scan before treatment and on study day 84 and 140.
- Biopsy of apparently normal skin before treatment and again on day 84.
- Review of medicines and well being on study days 0, 14, 28, 42, 56, 84, 112 and 140.
- Follow-up visits every 3 months for up 2 years for patients who have not received additional treatment for their cancer. Evaluations include physical exam, CT or MRI scan, PET CT scan, blood tests and possibly tumor biopsies....
|Renal Cell Carcinoma||Drug: Anti-Transforming Growth Factor-beta (GC 1008)||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase 1 Study of the Safety and Efficacy of GC1008: A Human Anti-Transforming Growth Factor-Beta (TGFBeta) Monoclonal Antibody in Patients With Advanced Renal Cell Carcinoma or Malignant Melanoma|
- To assess the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety of GC1008 in patients with locally advanced or metastatic renal cell carcinoma or malignant melanoma.
- To obtain pharmacokinetic (PK) and pharmacodynamic (PD) data on GC1008.
|Study Start Date:||July 9, 2006|
|Study Completion Date:||January 20, 2010|
|Primary Completion Date:||January 20, 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923169
|United States, New Jersey|
|Cancer Institute of New Jersey|
|Little Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Jay A Berzofsky, M.D.||National Cancer Institute (NCI)|