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An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma


Phase 1
25 Years
N/A
Not Enrolling
Both
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed incurable relapsed or refractory solid tumor or
non-Hodgkin's lymphoma that has been treated on MSKCC-01131

- 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jakob Dupont, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

REGENERON-VGF-ST-0105

NCT ID:

NCT00045266

Start Date:

April 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021