Treating Kidney Tumors in Patients With Von Hippel-Lindau Disease
Name of the Trial
Phase II Study of 17-N-Allylamino-17-Demethoxygeldanamycin in Patients With Von Hippel-Lindau Disease and Renal Tumors (NCI-04-C-0238). See the protocol summary.
Dr. W. Marston Linehan and Dr. Ramaprasad Srinivasan (Protocol Chair), NCI Center for Cancer Research.
Why Is This Trial Important?
Von Hippel-Lindau (VHL) disease is a rare inherited disorder characterized by the abnormal growth of tumors and/or cysts in the kidneys, eyes, brain, spinal cord, adrenal glands, and other parts of the body. While many of the tumors are benign (noncancerous), some-especially those of the kidney-may be malignant (cancerous). In fact, renal cell carcinomas are the major form of cancer in VHL disease and are seen in up to 45 percent of patients. The current standard treatment is surgical removal.
In this phase II trial, researchers are investigating whether treatment with 17AAG (17-N-Allylamino-17-Demethoxygeldanamycin) can effectively shrink kidney tumors in patients with VHL disease. Past research has shown that 17AAG can help cells eliminate proteins that play a role in cancer development and growth.
Patients in this study will receive three cycles of therapy over a three-month period. Patients whose tumors shrink with 17AAG treatment may continue to receive the drug for another 12 weeks. Those whose tumors do not shrink or that grow after 12 weeks will be asked to undergo surgery to remove their kidney tumors.
"If this drug is well-tolerated, it has the potential to reduce or eliminate the need for multiple surgeries in patients with VHL," said Dr. Linehan.
Who Can Join This Trial?
Researchers seek to enroll 16-25 patients aged 18 and over, diagnosed with VHL disease, who have one or more kidney tumors that pose a risk of spreading and for which surgical removal would be considered the standard approach. See the full list of eligibility criteria for this trial. As of August 26, 2005, this trial is temporarily closed. Patients interested in this trial may still contact the NCI Clinicial Studies Support Center for more information.
Where Is This Trial Taking Place?
This study is taking place at the NIH Clinical Center in Bethesda, Maryland.
For more information, call the NCI Clinical Studies Support Center (CSSC) toll free at 1-888-NCI-1937 or call the protocol coordinator, Sarah Fowler, R.N., in the Urologic Oncology Branch at 301-435-6255. The call is confidential.