Expired Study
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Columbus, Ohio 43210


Purpose:

RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.


Study summary:

OBJECTIVES: - Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma. - Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients. - Determine the pharmacokinetic profile of this drug in these patients. - Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks. Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD. Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed B-cell or T-cell lymphoma - Hodgkin's lymphoma and anaplastic large cell lymphoma eligible - No HIV-associated lymphoma - CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry - At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30 - Must meet one of the following criteria for relapsed/refractory disease: - Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) - Relapsed disease must be within the prior irradiated field - Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option - Disease progression must be within the prior irradiated field - Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined) PATIENT CHARACTERISTICS: Age - Over 12 Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - WBC at least 1,500/mm^3* - Neutrophil count at least 1,000/mm^3* - Platelet count at least 75,000/mm^3* - Hemoglobin at least 8.0 g/dL* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed Hepatic - AST no greater than 2 times upper limit of normal (ULN)* - Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)* - Hepatitis B surface antigen negative - Hepatitis C antibody negative NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed Renal - Creatinine no greater than 2 times ULN* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 9 months after study participation - HIV negative - No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No active significant infection - No apparent opportunistic infection, as indicated by any of the following: - Purified protein derivative recently determined to be positive - Infectious infiltrate by chest x-ray - Recent changes in fever/chill patterns - New, unexplained neurological symptoms - No underlying medical condition that would preclude receiving study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior anti-CD30 antibody therapy - No other concurrent biologic therapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent systemic steroidal therapy (excluding physiologic doses) Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent investigational agents


NCT ID:

NCT00059995


Primary Contact:

Study Chair
Steven M. Horwitz, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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