Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00045266
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
120 Years
Study:
NCT00045266
Study Brief:
Protocol Section:
NCT00045266