Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
Recurrent Melanoma, Stage III Melanoma, Stage IV Melanoma

About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of 1 of the following: Metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective (phase I) (phase I study closed to accrual as of 8/23/04) Melanoma (phase I and II) Measurable disease (phase II) No history or clinical evidence of CNS disease, including primary brain tumor or brain metastases Performance status - ECOG 0-1 More than 3 months WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of bleeding diathesis or coagulopathy Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN INR no greater than 1.5 APTT normal Creatinine no greater than 2.0 times ULN Creatinine clearance at least 40 mL/min No proteinuria Urinary protein less than 500 mg/24 hours No history of stroke No uncontrolled hypertension within the past 6 months Blood pressure less than 150/100 mm Hg on a stable antihypertensive regimen None of the following within the past 6 months: Myocardial infarction Unstable angina New York Heart Association class II-IV congestive heart failure Serious cardiac arrhythmia requiring medication Grade II or greater peripheral vascular disease Transient ischemic attack Cerebrovascular accident Other arterial thromboembolic event Other clinically significant cardiovascular disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 3 months after study participation No seizures not controlled with standard medical therapy No prior allergic reactions attributed to Chinese hamster ovary cell products, other recombinant human antibodies, or compounds of similar chemical or biological composition to imatinib mesylate No serious, nonhealing wound, ulcer, or bone fracture No ongoing or active infection requiring parenteral antibiotics No significant traumatic injury within the past 28 days No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness More than 4 weeks since prior immunotherapy More than 8 weeks since prior monoclonal antibody therapy No concurrent prophylactic granulocyte or platelet colony-stimulating factors More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No more than 1 prior cytotoxic chemotherapy regimen for advanced disease (phase II) More than 4 weeks since prior radiotherapy More than 28 days since prior major surgical procedure or open biopsy Recovered from prior therapy No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function No recent or concurrent full-dose anticoagulants (except as required to maintain patency of preexisting permanent indwelling IV catheters) or thrombolytic agent No concurrent grapefruit juice No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial agents or therapies directed at the malignancy No other concurrent investigational agents
Sites / Locations
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.