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Phase I Study of Intravenous VEGF Trap in Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase I | Treatment | Closed | 18 and over | MSKCC-03138
REGENERON-VGFT-ST-0304, NCT00082823 |
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 the steady-state pharmacokinetics of this drug in these patients.
- Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients.
- Determine whether antibodies to this drug develop in these patients.
- Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients.
Entry Criteria 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)
Prior/Concurrent Therapy:
Biologic therapy - No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
Chemotherapy Endocrine therapy - No concurrent adrenal corticosteroids, except low-dose replacement therapy
- No concurrent systemic hormonal contraceptive agents
Radiotherapy Surgery 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - No severe or uncontrolled hematologic condition
Hepatic 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
Expected Enrollment 25A total of 25 patients will be accrued for this study within 3-6 months. Outline This is an open-label, multicenter, extension study. Patients receive VEGF Trap* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. [Note: *Patients receive the same drug dose that they received in MSKCC-03137 (VGFT-ST-0202)] Patients are followed monthly for 3 months.
Trial Contact Information
Trial Lead Organizations Memorial Sloan-Kettering Cancer Center | | | | William Tew, MD, Principal investigator | | | |
Related Information PDQ® clinical trial MSKCC-03137
| Registry Information | | | Official Title | | An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients with Advanced Solid Tumors or Lymphoma | | | Trial Start Date | | 2004-01-13 | | | Trial Completion Date | | 2010-01-13 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00082823 | | | Date Submitted to PDQ | | 2004-03-03 | | | Information Last Verified | | 2007-10-11 | | | NCI Grant/Contract Number | | CA08748 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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