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Home > "I" Clinical Trials Conditions > Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers  Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
For Condition: Recurrent Melanoma,Stage 4 Melanoma,unspecified adult solid tumor, protocol specific,stage 3 melanoma
Status: Recruiting
Sponsor(s): University of Pennsylvania Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells. PURPOSE: Phase I/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.
Details: OBJECTIVES: - Determine the tolerability, maximum tolerated dose, and lowest biologically active dose of imatinib mesylate and bevacizumab in patients with advanced melanoma or other advanced cancers. - Determine the response rate, time to progression, and survival of patients treated with this regimen. - Correlate clinical activity with inhibition of platelet-derived growth factor receptor beta, vascular endothelial growth factor receptor, flt-1, and markers of angiogenesis in patients treated with this regimen. - Correlate clinical activity with alterations in tumor perfusion as assessed by dynamic contrast-enhanced MRI and Doppler ultrasound in patients treated with this regimen. - Correlate toxicity, clinical activity, and correlative endpoints with the steady-stage plasma concentration of imatinib mesylate in patients treated with this regimen. OUTLINE: This is a dose-escalation, open-label study. - 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. Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive imatinib mesylate and bevacizumab as in phase I at the MTD. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 6 months. A total of 23-40 patients will be accrued for the phase II portion of this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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) - Melanoma (phase I and II) - Measurable disease (phase II) - No history or clinical evidence of CNS disease, including primary brain tumor or brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - More than 3 months Hematopoietic - 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 Hepatic - 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 Renal - Creatinine no greater than 2.0 times ULN OR - Creatinine clearance at least 40 mL/min - No proteinuria OR - Urinary protein less than 500 mg/24 hours Cardiovascular - No history of stroke - No uncontrolled hypertension - Blood pressure less than 150/100 mm Hg on a stable antihypertensive regimen - None of the following within the past year: - Clinically significant cardiovascular disease - 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 Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - 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 Chemotherapy - 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) Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - More than 28 days since prior major surgical procedure or open biopsy Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KeithFlaherty, Principal Investigator, University of Pennsylvania Cancer Center
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Keith Flaherty 215-662-8624
Additional Information:
Study ID Numbers: CDR0000343804; UPCC-03903,NCI-6006
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074308
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors
2. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
3. Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
5. CCI-779 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
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