At a glance
ClinicalIndex Comparison Record- ✓Clinical diagnosis of von Hippel-Lindau disease
- ✓Presence of one or more localized renal tumors suitable for surgical resection
- ✓Age ≥18 years
- ✓ECOG performance status 0-2
- ✕Any renal tumor >4 cm in size
- ✕Prior or concomitant non-VHL associated malignancy (except adequately treated basal/squamous cell skin cancer or disease-free >5 years)
- ✕Metastatic renal cell cancer
- ✕Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) with unresolved adverse events
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of 17-Allylamino-17-Demethoxygeldanamycin in Patients With Von Hippel Lindau Disease and Renal Tumors
In Brief
A Phase 2 clinical trial evaluating 17 allylamino-17-demethoxygeldanamycin, 18 FDG (Fludeoxyglucose 18F), and 2 other interventions for Hippel-Lindau Disease and Kidney Cancer. Completed, enrolled 9 participants across 1 site.
Detailed Summary
This study will examine whether the drug 17AAG (17-allylamino 17-demethoxygeldanamycin) can shrink kidney tumors in patients with Von Hippel-Lindau disease (VHL), a rare, inherited syndrome in which patients develop tumors in certain parts of the body. 17AAG contributes to the destruction of proteins in cells that may play in role in causing cancer and spurring tumor growth. The study will also look at the effect of 17AAG on other tumors patients may have that are caused by VHL, on the amount of blood vessels in the tumors, on the biologic activity of the tumor, and on cells circulating in the bloodstream, as well as the safety of the drug and its impact on the kidney tumor in patients whose tumor(s) is removed. Patients 18 years of age and older with von Hippel-Lindau disease who have at least one kidney tumor large enough to pose a risk of metastasis (spread of cancer to other parts of the body) may be eligible for this study. Candidates are screened with a medical history and physical examination, computed tomography (CT) scan, brain magnetic resonance imaging (MRI), see below), 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. Participants undergo the following tests and procedures: MRI: This test uses a strong magnetic field and radio waves to show structural and chemical changes in tissue. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields. A catheter (plastic tube) is inserted into the patient's arm to administer a contrast dye that enhances the images. 17AAG treatment: Patients receive 17AAG infusions into a vein once a week for 3 weeks out of every 4, for 3 months. The infusions last up to 1 to 2 hours. Repeat testing: After 3 months, patients have repeat MRI scans to measure changes in tumor activity, blood flow, and number of blood vessels in the tumor since the pretreatment scans. They may have additional tests, including a CT scan, eye exam, and other tests to evaluate the effect of 17AAG on the tumors.
Study Details
Timeline
Interventions
17 allylamino-17-demethoxygeldanamycin (17 AAG) given intravenously at a dose of 300 mg/m2 on days 1,8 and 15 of 28 day cycles.
18FDG PET performed at baseline and 12 weeks after treatment. At each timepoint participants can receive 250mCi 0-15 water and 15 mCi F18-FDG.
\[15-0\] H20 performed at baseline and 12 weeks after treatment. At each time point participants can receive 250mCi 0-15 water and 15 mCi F18-FDG. The water scans were done as several intravenous injections for several scans but not over a total of 250 mCi.
17AAG is formulated with this diluent. Supplied in a 50 mL flint vial containing 48 mL of 2% egg phospholipids, and 5% dextrose in Water for Injection, USP. Patients with a history of serious allergic reactions to eggs should not receive this agent.