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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Sunitinib will be given PO once daily on days 1-14 of each 21 day cycle. The exact dose of sunitinib will be determined during the Phase I part of the trial.
Dacarbazine will be given at 1000 mg/m2 on day 1 of every 21 day cycle.
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
To determine the toxicity and safety of this combination and determine the recommended Phase II dose of this combination.
Time frame: 6 months
To determine the overall response rate of the combination of sunitinib and DTIC as the first line treatment in stage IV malignant melanoma.
Time frame: 4 months
To determine the progression free survival (PFS) of disease of patients treated with the combination of sunitinib and DTIC.
Time frame: 2 years
To determine Overall Survival of patients treated with this combination.
Time frame: 5 years
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