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An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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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 CenterNashville, Tennessee  37232-6838
Memorial Sloan - Kettering Cancer CenterNew York, New York  10021