Part 2 of Phase 1 Study of GC1008 to Treat Advanced Melanoma (Part 2 Will Only Accept and Treat Patients With Advanced Malignant Melanoma)

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT00923169
Run by: National Cancer Institute (NCI)
People needed: 9
Starts: 2006-07-09
Expected to finish: 2010-01-20
Last updated by the study team: 2019-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Central nervous system (CNS) metastases, meningeal carcinomatosis, malignant seizures, or a disease that either causes or threatens neurologic compromise (e.g., unstable vertebral metastases).
History of ascites or pleural effusions, unless successfully treated, completely resolved, and the patient has not been treated for these conditions for greater than 4 months.
Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or use of anti-coagulation therapy (including anti-platelet agents). Patients with a history of deep venous thrombosis may participate if successfully treated, completely resolved, and no treatment has been given for greater than 4 months.
Hypercalcemia: Calcium greater than 11.0 mg/dL (2.75 mmol/L) unresponsive or uncontrolled in response to standard therapy (e.g., bisphosphonates).
Pregnant or nursing women, due to the unknown effects of GC1008 on the developing fetus or newborn infant.
Patients diagnosed with another malignancy - unless following curative intent therapy, the patient has been disease free for at least 5 years and the probability of recurrence of the prior malignancy is less than 5 percent. Patients with curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are eligible for this study.
Patients with an organ transplant, including those that have received an allogeneic bone marrow transplant.
Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent such as a monoclonal antibody).
Patients on immunosuppressive therapy including:
Systemic corticosteroid therapy for any reason, including replacement therapy for hypoadrenalism. Patients receiving inhaled or topical corticosteroids may participate.
Patients receiving cyclosporine A, tacrolimus, or sirolimus are not eligible for this study.
Significant or uncontrolled medical illness, such as congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with a remote history of asthma or active mild asthma may participate.
Active infection, including unexplained fever (temperature greater than 38.1 YC), or antibiotic therapy within 1 week prior to enrollment.
Systemic autoimmune disease (e.g., systemic lupus erythematosus, active rheumatoid arthritis, etc.).
A known allergy to any component of GC1008.
Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include, but are not limited to:
Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis) or significantly increase the risk of SAEs.
Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment.).
Patients currently abusing drugs or alcohol or, in the opinion of the Investigator, at high for poor compliance.
Part 2 only: Prior therapy with a TGFBeta antagonist, such as an antibody, receptor, or kinase inhibitor or anti-sense therapy.

Where it is running

Cancer Institute of New Jersey — Little Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.