Status:
COMPLETED
VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Ciliary Body and Choroid Melanoma, Medium/Large Size
Extraocular Extension Melanoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological substances in ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the antitumor response rate (complete and partial response) in patients with recurrent inoperable stage III or IV melanoma treated with VEGF Trap. II. Compare the pr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed stage III or IV melanoma
- Cutaneous, ocular, or mucosal melanoma allowed
- Recurrent, inoperable disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No evidence of CNS disease, including primary brain tumor or brain metastases
- No brain metastases by MRI or CT scan within the past 4 weeks
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Urine protein:creatinine ratio \< 1 OR urine protein \< 500 mg by 24-hour urine collection
- PT INR ≤ 1.5 unless on full-dose warfarin
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to agents used in the study
- No serious or nonhealing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- No significant traumatic injury within the past 28 days
- No clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident within the past 6 months
- Uncontrolled hypertension, defined as blood pressure (BP) \> 150/100 mm Hg or systolic BP \> 180 mm Hg if diastolic BP \< 90 mm Hg within the past 3 months
- Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
- New York Heart Association class III-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Unstable angina pectoris within the past 6 months
- Clinically significant peripheral vascular disease within the past 6 months
- Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
- No evidence of bleeding diathesis or coagulopathy
- No concurrent uncontrolled illness, including, but not limited to any of the following:
- Ongoing or active infection
- Psychiatric illness or social situation that would preclude study compliance
- Recovered from all prior therapy and major surgery
- No prior chemotherapy or hormonal therapy
- More than 7 days since prior core visceral organ biopsy
- More than 4 weeks since prior biologic therapy or radiotherapy
- More than 28 days since prior major surgery or open biopsy
- No concurrent major surgery
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent full-dose warfarin with PT INR \> 1.5 allowed provided the following criteria are met:
- INR in range (2-3) on a stable dose of oral anticoagulant or low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00450255
Start Date
June 1 2007
End Date
January 1 2011
Last Update
May 24 2018
Active Locations (1)
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1
City of Hope
Duarte, California, United States, 91010