Expired Study
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Stanford, California 94305


Purpose:

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with monoclonal antibody Hu1D10. - Determine the duration of response and progression-free survival of patients treated with this drug. - Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity. Patients are followed at weeks 5 and 8 and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within approximately 12 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed Hodgkin's lymphoma - Progressive or recurrent disease after standard initial therapy - At least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques) - Patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation - Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - HIV negative - No known human anti-human antibody - No prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody Hu1D10 - No ongoing or active infection - No other uncontrolled concurrent illness - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - See Chemotherapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior second-line (or greater) high-dose therapy and stem cell transplantation allowed Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - No other concurrent investigational agents - No other concurrent anticancer agents or therapies


NCT ID:

NCT00055783


Primary Contact:

Study Chair
Sandra J. Horning, MD
Stanford University


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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