An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
18 Years
N/A
Both
Cancer
Trial Information
An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
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.
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.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3-6 months.
Inclusion 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)
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
William P. Tew, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
REGENERON-VGFT-ST-0304
NCT ID:
NCT00082823
Start Date:
January 2004
Completion Date:
Related Keywords:
- Cancer
- recurrent grade 1 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse large cell lymphoma
- stage IV adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- stage IV adult Burkitt lymphoma
- recurrent mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- unspecified adult solid tumor, protocol specific
- recurrent adult soft tissue sarcoma
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- recurrent cervical cancer
- stage IVA cervical cancer
- stage IVB cervical cancer
- fallopian tube cancer
- ovarian sarcoma
- recurrent ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent endometrial carcinoma
- stage IV endometrial carcinoma
- recurrent uterine sarcoma
- stage IV uterine sarcoma
- recurrent ovarian germ cell tumor
- stage IV ovarian germ cell tumor
- ovarian stromal cancer
- recurrent vaginal cancer
- stage IVA vaginal cancer
- stage IVB vaginal cancer
- recurrent prostate cancer
- stage IV prostate cancer
- recurrent penile cancer
- stage IV penile cancer
- recurrent malignant testicular germ cell tumor
- stage III malignant testicular germ cell tumor
- recurrent bladder cancer
- stage IV bladder cancer
- recurrent vulvar cancer
- stage IVB vulvar cancer
- distal urethral cancer
- proximal urethral cancer
- recurrent urethral cancer
- urethral cancer associated with invasive bladder cancer
- primary peritoneal cavity cancer
- 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
- stage IV adult soft tissue sarcoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Memorial Sloan - Kettering Cancer Center | New York, New York 10021 |
