VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00045266 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 3, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma Unspecified Adult Solid Tumor, Protocol Specific | Biological: ziv-aflibercept | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma |
| Study Start Date : | April 2002 |
| Actual Primary Completion Date : | February 2007 |
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| Ages Eligible for Study: | 25 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed incurable relapsed or refractory solid tumor or non-Hodgkin's lymphoma that has been treated on MSKCC-01131
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045266
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Jakob Dupont, MD | Memorial Sloan Kettering Cancer Center |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00045266 History of Changes |
| Other Study ID Numbers: |
REGENERON-VGF-ST-0105 MSKCC-02020 CDR0000256462 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-G-02-2101 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 3, 2016 |
| Last Verified: | June 2016 |
Keywords provided by Regeneron Pharmaceuticals:
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recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Burkitt lymphoma |
stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma unspecified adult solid tumor, protocol specific recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage IV small lymphocytic lymphoma stage IV marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Additional relevant MeSH terms:
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |