Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to Follow
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|ClinicalTrials.gov Identifier: NCT00330564|
Recruitment Status : Terminated (Slow accrual.)
First Posted : May 29, 2006
Results First Posted : June 30, 2011
Last Update Posted : February 27, 2012
The goal of this clinical research study is to learn if sunitinib malate (SU011248) can help to control VHL. The safety of this drug will also be studied.
- Evaluate safety of treatment with SU011248/sunitinib malate (50 mg daily dose for 4 weeks, then 2 weeks off) for 6 months in patients with Von Hippel-Lindau Syndrome (VHL) who have a measurable lesion undergoing surveillance
- Evaluate efficacy of treatment with SU011248/sunitinib malate (50 mg daily dose for 4 weeks, then 2 weeks off) for 6 months in patients with VHL who have a measurable lesion undergoing surveillance
- Evaluate quality of life of SU011248/sunitinib malate therapy in VHL patients
- Evaluate peripheral blood lymphocyte receptor phosphorylation in VHL patients taking SU011248/sunitinib malate (optional procedure)
- Correlate results of dynamic contrast-enhanced and diffusion weighted MRI and dynamic contrast enhanced CT with response and explore findings suggestive of surrogates of early response (optional procedure)
|Condition or disease||Intervention/treatment||Phase|
|Von Hippel-Lindau Syndrome Renal Cell Carcinoma Hemangioblastoma||Drug: SU011248||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of SU011248 (Sunitinib Malate) in Von Hippel-Lindau Syndrome|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Experimental: SU011248 (Sutent, Sunitinib Malate)
50 mg/day orally for 4 weeks
50 mg/day orally for 4 weeks, no treatment for 2 weeks (6 weeks = 1 cycle).
- Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL) [ Time Frame: 12 weeks ]Safety evaluation = Number of participants with treatment terminating toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0. Early stopping rules applied when treatment terminating toxicity occurred in the first 6 week cycle. Recurring grade 3 toxicity requires dose reduction, with no more than 2 dose reductions permitted. If no improvement after 4 weeks, patient is taken off drug and off study, and the event recorded as treatment terminating toxicity.
- Number of VHL Lesion Complete + Partial Responses [ Time Frame: Baseline to 12 months (evaluations at 6 and 12 months) ]Response of VHL lesions (number) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): 20% increase in LD sum and Stable Disease (SD): Insufficient shrinkage to qualify for PR nor increase to qualify for PD. Degree and timing of response in affected organs evaluated in order to determine organ specific kinetics of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330564
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric Jonasch, MD||M.D. Anderson Cancer Center|