Status:
COMPLETED
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage III Melanoma
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in treating patients who have advanced melanoma or other metastatic or unresectable cancer. Imatinib mesylate ...
Detailed Description
OBJECTIVES: I. Determine the tolerability, maximum tolerated dose, and lowest biologically active dose of imatinib mesylate and bevacizumab in patients with advanced melanoma or other advanced cancer...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00074308
Start Date
October 1 2003
End Date
July 1 2009
Last Update
June 20 2018
Active Locations (1)
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1
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104