- 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
-To determine the frequency of adverse skin side effects of GC1008 in patients with malignant
-Patients 18 years of age and older with malignant melanoma for whom previous treatment was
- 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.