Status:
COMPLETED
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. PURPOSE: This phase I trial is studying the side effects of VEGF T...
Detailed Description
OBJECTIVES: Primary * Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. Secondary * Determine ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites:
- Liver
- Soft tissue
- Pelvis
- Other site that is suitable for delayed contrast-enhancing MRI
- Relapsed or refractory disease
- Failed all conventional therapeutic options AND not amenable to existing therapeutic options
- Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity
- No prior or concurrent CNS metastases (brain or leptomeningeal)
- No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202)
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- No severe or uncontrolled hematologic condition
- Hepatic
- Not specified
- Renal
- No severe or uncontrolled renal condition
- Cardiovascular
- No severe or uncontrolled cardiovascular condition
- Pulmonary
- No severe or uncontrolled pulmonary condition
- Other
- No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition
- No other medical or psychiatric condition or adverse social circumstance that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
- Chemotherapy
- Not specified
- Endocrine therapy
- No concurrent adrenal corticosteroids, except low-dose replacement therapy
- No concurrent systemic hormonal contraceptive agents
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors
- No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin
- Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed
- No other concurrent standard or investigational agents for this malignancy
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00082823
Start Date
January 1 2004
Last Update
June 3 2016
Active Locations (2)
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1
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838