Von Hippel-Lindau
A Phase II Study of 17-Allylamino-17-Demethoxygeldanamycin in Patients With Von Hippel Lindau Disease and Renal Tumors
NCI-04-C-0238
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Investigator(s): |
W. Marston Linehan, M.D.
Principal Investigator
Phone: 301-496-6353
linehanm@mail.nih.gov
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Primary Eligibility:
- ≥ 18 years of age
- Clinical diagnosis of von Hippel-Lindau disease
- Presence of one or more localized renal tumors ≤ 4 cm in size
- Willingness to undergo resection of renal tumor at the time point defined in the protocol
- No metastatic renal cell cancer
- Normal organ and marrow function
- No history of another serious medical illness
Treatment Plan:
- Candidates are screened with a medical history, cardiac evaluation and physical examination, computed tomography (CT) scan, brain magnetic resonance imaging (MRI), and blood and urine tests; additional tests, including a 24-hour urine collection, ultrasound of the testicles in men, hearing test, eye exam, and MRI of the spine, may be done if recent test results are not available
- Patients receive 17AAG infusions into a vein once a week for 3 out of every 4 weeks, for 3 months; the infusions last up to 1–2 hours
- After 3 months, patients have repeat MRI and PET scans to measure changes in tumor activity, blood flow, and number of blood vessels in the tumor since the pre-treatment scans; they may have additional tests, including a CT scan, eye exam, and other tests to evaluate the effect of 17AAG on the tumors
- Patients whose tumors shrink with 17AAG treatment may continue to receive the drug for another 12 weeks, followed by repeat MRI and PET scans
- Patients who do not demonstrate a partial or complete response of their renal tumors following 3 cycles of therapy, or continue to have at least one tumor ≥ 3 cm despite a partial response, will be taken off the study and can undergo standard resection of their renal tumor(s) to minimize their risk of metastasis
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 12/4/08
Updated: 10/14/08
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