Protocol Number: 06-C-0200

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

Number:

06-C-0200

Summary:

This study will examine the safety and effectiveness of GC1008, an antibody drug, on advanced cancer of the kidneys and malignant melanoma, an aggressive form of skin cancer. Researchers are interested in the tumor-fighting action of GC1008 on a molecule known as transforming growth factor-beta (TGF ), which has been linked to the progression and spread of existing cancers.

Patients, ages 18 and older who have kidney cancer or melanoma that is inoperable or that has spread and has not responded to at least one type of chemotherapy treatment, and who are not pregnant or breastfeeding may be eligible for this study. The study will last for about 5 months and consist of about 13 study visits. There will be follow-up for 2 years, involving study visits every 3 months. Patients will undergo procedures that include a medical history, blood and urine tests, X-rays, electrocardiograms, computed tomography (CT) scans, bone scans, and magnetic resonance imaging (MRI) scans. Up to 36 participants will receive one of six dose levels of GC1008. The TGF solution will be given by injection into a vein. Treatment will take from 30 minutes to 3 hours, depending on the dose given. After the first dose, patients will be monitored for 4 weeks and the blood levels of GC1008 will be measured. If there are no major side effects, patients will receive three additional doses of GC1008 at the same dose, 2 weeks apart. Then if evaluations after the first four doses of CG1008-that is, the first course-show that the cancer is responding, patients may be able to receive more courses of treatment.

During a CT scan, patients lie on a table and pass through a machine that uses an X-ray beam to allow detailed internal views of the body. For the bone scan, patients lie on a table while images are made possible through a radioactive tracer that is given by injection. Both of these scans use low levels of radiation. An MRI scan uses a magnetic field to take internal pictures of the body. Patients lie on a table that slides into a machine. During the first 5 months of the study, about 2 cups of blood will be collected for research purposes. If a patient's cancer responds to GC1008 and he or she receives extended treatment with the drug, then about 3 tablespoons of additional blood will be collected for each additional course of GC1008 administered.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Renal Cell

Melanoma

Monoclonal Antibodies

Phase I

TGF-B

Recruitment Keyword(s):

None

Condition(s):

Renal Cell Carcinoma

Investigational Drug(s):

Anti-Transforming Growth Factor-beta (GC 1008)

Investigational Device(s):

None

Interventions:

Drug: Anti-Transforming Growth Factor-beta (GC 1008)

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Bandyopadhyay A, Zhu Y, Cibull ML, Bao L, Chen C, Sun L. A soluble transforming growth factor beta type III receptor suppresses tumorigenicity and metastasis of human breast cancer MDA-MB-231 cells. Cancer Res. 1999 Oct 1;59(19):5041-6. Related Articles, Links

Blobe GC, Schiemann WP, Lodish HF. Role of transforming growth factor beta in human disease. N Engl J Med. 2000 May 4;342(18):1350-8.

Derynck R, Akhurst RJ, Balmain A. TGF-beta signaling in tumor suppression and cancer progression. Nat Genet 2001 Nov;29(3):351.

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