Name of the Trial
Phase I Study of Human Anti-TGF-Beta Monoclonal Antibody GC1008 in Patients with Unresectable Locally Advanced or Metastatic Renal Cell Carcinoma or Malignant Melanoma (NCI-06-C-0200).  See the protocol summary at http://cancer.gov/clinicaltrials/NCI-06-C-0200.

Principal Investigator
Dr. John C. Morris, NCI Center for Cancer Research

Why This Trial Is Important
Many cellular proteins have been identified that play a role in the development and progression of cancer. These proteins initiate or transmit signals that help cancer cells 1) grow and evade the process of programmed cell death (apoptosis), 2) stimulate the growth of new blood vessels (angiogenesis) to ensure tumors have an adequate supply of nutrients, 3) break away from the initial tumor site and spread to other locations in the body (metastasize), or 4) block the body's immune response against tumors.

One of these proteins is called transforming growth factor beta (TGF-β), which is overproduced by many types of cancer cells. Therefore, researchers are interested in developing new drugs or biological agents that can bind to and possibly block the activity of this protein.

This trial will assess the safety and tolerability of a new biological agent called GC1008 in patients with advanced kidney cancer or melanoma. GC1008 is a monoclonal antibody specifically designed to target TGF-β and block its activity.

"TGF-β is known to play a major role in the progression of kidney cancer and melanoma, two types of cancer that are notoriously difficult to treat when advanced," said Dr. Morris. "We hope that treatment with GC1008 suppresses TGF-β in these tumors and leads to a delay in cancer progression or even causes tumors to shrink."

Who Can Join This Trial
Researchers will enroll 36 patients aged 18 or over with inoperable locally advanced or metastatic renal cell carcinoma or melanoma that has not responded to previous treatment. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-06-C-0200. 

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/NCI-06-C-0200 or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.