Expired Study
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Lebanon, New Hampshire 03756


Purpose:

RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic lymphocytic leukemia. - Assess the clinical toxicity of this antibody in these patients. OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22. Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1 year. PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia - Primary refractory or multiply relapsed (after at least 2 prior chemotherapy regimens) disease - Ineligible for bone marrow or peripheral blood stem cell transplantation PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - Alkaline phosphatase less than 2 times normal - SGPT less than 2 times normal Renal: - Creatinine clearance greater than 50 mL/min Other: - No human-anti-murine-antibody response to prior murine monoclonal antibodies - No immunological or inflammatory disease (e.g., lupus erythematosus) - No active serious infection - No other serious medical condition that would limit survival to less than 2 years - No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix - No psychiatric or addictive disorder that would preclude study - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior immunotherapy allowed Chemotherapy: - See Disease Characteristics - No concurrent chemotherapy Endocrine therapy: - Concurrent steroids for adrenal failure or adverse reactions to study drug allowed - Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed Radiotherapy: - Not specified Surgery: - Not specified


NCT ID:

NCT00014560


Primary Contact:

Study Chair
Pamela Ely, MD
Norris Cotton Cancer Center


Backup Contact:

N/A


Location Contact:

Lebanon, New Hampshire 03756
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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