RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by
stopping blood flow to the cancer.
PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have
relapsed or refractory solid tumors or non-Hodgkin's lymphoma.
- Determine the long-term safety and tolerability of VEGF Trap in patients with incurable
relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding
disease after receiving treatment on protocol MSKCC-01131.
- Determine the biological effect of this therapy on suppressing tumor growth or
progression in these patients.
- Determine the steady state concentration of VEGF Trap over time in these patients.
- Determine whether patients develop antibodies to this therapy during extended exposure.
OUTLINE: This is an extension study for patients who showed evidence of stable disease or
complete or partial remission after completing treatment on protocol MSKCC-01131.
Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6
months in the absence of unacceptable toxicity. Patients receive treatment at the same dose
level as on protocol MSKCC-01131.
Patients are followed at approximately 30 days.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
- Histologically confirmed incurable relapsed or refractory solid tumor or
non-Hodgkin's lymphoma that has been treated on MSKCC-01131
- Must have completed participation in protocol MSKCC-01131 through visit 16 and have
shown evidence of stable disease or complete or partial remission of tumor burden and
no evidence of symptomatic deterioration
- No adverse event or toxicity which resulted in discontinuation of participation
in protocol MSKCC-01131
- If a patient experienced dose-limiting toxicity, then the patient must have
demonstrated the ability to tolerate the same dose or a lower dose prior to
entry in this study
- No known or suspected squamous cell carcinoma of the lung
- No prior or concurrent new neurological symptoms or CNS (brain or leptomeningeal)
metastases during protocol MSKCC-01131
- 25 and over
- ECOG 0-2
- Not specified
- WBC at least 3,500/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9.0 g/dL
- No severe or uncontrolled hematologic condition
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 2 times ULN
- Alkaline phosphatase no greater than 2 times ULN
- PT, PTT, and INR normal
- Creatinine no greater than ULN
- No 1+ or greater proteinuria
- No severe or uncontrolled renal condition
- No severe or uncontrolled cardiovascular condition
- No severe or uncontrolled pulmonary condition
- No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap)
- No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal
- No severe or uncontrolled psychiatric condition or adverse social circumstance that
would preclude study
- No other condition that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception during and for at
least 3 months after study
PRIOR CONCURRENT THERAPY:
- No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
- No other concurrent immunotherapy
- No concurrent standard chemotherapy
- No concurrent adrenal corticosteroids except low doses as replacement therapy in
patients who have previously received suppressive doses or for adrenal insufficiency
- No concurrent systemic hormonal contraceptive agents
- No concurrent radiotherapy
- Not specified
- At least 30 days since prior investigational therapy other than VEGF Trap
- No concurrent standard or other investigational anticancer agents
- No concurrent herbal supplements ("nutraceuticals")
- No concurrent anticoagulant or antiplatelet drugs (e.g., warfarin, heparin, aspirin,
or other nonsteroidal anti-inflammatory drugs) except selective cyclo-oxygenase-2
(COX-2) inhibitors for analgesia
- No concurrent COX-2 inhibitors for tumor treatment or prophylaxis