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Home > "V" Clinical Trials Conditions > VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma  VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
For Condition: adult non-Hodgkin's lymphoma,adult solid tumor
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 25 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - 25 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - 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 Hepatic - 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 Renal - Creatinine no greater than ULN - No 1+ or greater proteinuria - No severe or uncontrolled renal condition Cardiovascular - No severe or uncontrolled cardiovascular condition Pulmonary - No severe or uncontrolled pulmonary condition Other - No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap) - No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition - 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: Biologic therapy - No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) - No other concurrent immunotherapy Chemotherapy - No concurrent standard chemotherapy Endocrine therapy - 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 Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JakobDupont, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting David Spriggs 212-639-2203
Additional Information:
Study ID Numbers: CDR0000256462; REGENERON-VGF-ST-0105,MSKCC-02020,NCI-G-02-2101
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045266
Other Adult Solid Tumor Studies:
1. VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
2. Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
3. Pegfilgrastim Compared With Filgrastim To Increase Peripheral Stem Cells Before Autologous Stem Cell Transplantation in Treating Patients With Lymphoma
4. Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
5. Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers
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VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
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