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More info
You can access this
clinical trial
if you have
Renal Cell Carcinoma
and you are
over 18
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Background: - 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. Objectives: -To determine the frequency of adverse skin side effects of GC1008 in patients with malignant melanoma. Eligibility: -Patients 18 years of age and older with malignant melanoma for whom previous treatment was not successful. Design: - 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.

Provided treatments

  • Drug: Anti-Transforming Growth Factor-beta (GC 1008)
Tris trial is registered with FDA with number: NCT00923169. The sponsor of the trial is National Cancer Institute (NCI) and it is looking for 9 volunteers for the current phase.
Official trial 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