Melanoma Clinical Trial
Official title:
A Phase I/II Study of Sunitinib and Dacarbazine in Patients With Metastatic Melanoma
This is a combination Phase I/II design that explores the toxicity and activity of Sunitinib and Dacarbazine (DTIC) for metastatic melanoma. The initial Phase I part of this trial will consist of a dose escalation of sunitinib while keeping the DTIC dose constant. If no DLT is seen, this dose will be the suggested Phase II trial dose. If less than 2 disease responses are seen, patients will not be enrolled any further, and the study will be considered negative for activity. If a clinical response is seen, patients will continue to be enrolled.
This is a combination Phase I/II design that explores the toxicity and activity of a
combination of sunitinib and Dacarbazine (DTIC) for metastatic melanoma. Screening tests
(pre-study) will consist of a history, physical, CBC, CMP, EKG, pregnancy test for women of
childbearing age, amylase (blood test for diagnoses of pancreatitis or other pancreatic
diseases), staging CT, and PK. Also, on day 1, these tests will be repeated - a history,
physical, toxicity assessment, CBC, and amylase test. Re-staging tests will be performed
after 2 complete cycles and follow up as indicated clinically.
The initial Phase I part of this trial will consist of a dose escalation of sunitinib while
keeping the DTIC dose constant. Sunitinib will be given 2 weeks on and 1 week off with DTIC
given once every 21 days for one cycle. If no DLT is seen, the maximum tolerated sunitinib
dose will be the suggested as the Phase II trial dose.
Tumor response will be measured after 2 complete cycles. Subsequently, during Phase II the
trial will enroll more patients; if less than 2 responses are seen, patients will not be
enrolled any further, and the study will be considered negative for activity. But, if a
clinical response is seen, more patients will be enrolled at the Phase II dose.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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