Expired Study
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Stanford, California 94305


Purpose:

RATIONALE: Monoclonal 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 monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.


Study summary:

OBJECTIVES: - Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas. - Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population. - Determine the response in these patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 1 month and then monthly for 3 months. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed CD3+ T-cell lymphoma for which no standard curative therapy exists - Peripheral T-cell lymphoma - Recurrent and/or progressive disease after at least 1 prior therapy - Mycosis fungoides - Stage IB/IIA - Recurrent and/or progressive disease after at least 2 prior therapies - Stage IIB-IVB - Recurrent and/or progressive disease after at least 1 prior therapy - All other T-cell lymphomas - Recurrent and/or progressive disease after at least 1 prior therapy - Evaluable disease - Any nodal site or mass lesion at least 1.5 cm in longest axis on physical exam or CT scan - Skin lesions at least 1 cm in longest axis for cutaneous lymphoma - High numbers of circulating T-cells allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 - Karnofsky 50-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm^3* - Absolute neutrophil count at least 1,000/mm^3* - Platelet count at least 75,000/mm^3* NOTE: * Unless due to lymphoma Hepatic: - Bilirubin no greater than 2.0 times normal* - AST/ALT no greater than 2.5 times upper limit of normal* - Hepatitis B and C negative NOTE: * Unless due to lymphoma Renal: - Not specified Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No other uncontrolled illness - No ongoing or active infection - No other active malignancies except basal cell skin cancer or carcinoma in situ of the cervix - HIV-1 negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics Biologic therapy: - At least 60 days since prior humanized or chimeric antibody therapy Chemotherapy: - At least 3 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 3 weeks since prior radiotherapy Surgery: - Not specified Other: - At least 30 days since prior investigational drugs or therapies


NCT ID:

NCT00006009


Primary Contact:

Study Chair
Youn H. Kim, 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: September 23, 2017

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