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Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma



Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

For Condition: Leukemia,Lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Stanford University
Synopsis: 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.
Details: OBJECTIVES: I. Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas. II. Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population. III. Determine the response in these patients treated with this regimen. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2; Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 2,000/mm3* Absolute neutrophil count at least 1,000/mm3* Platelet count at least 75,000/mm3* * 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 * 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
YounKim,  Study Chair,  Stanford University

Stanford University Medical Center
Stanford,  California,  94305-5408
United States
 


Additional Information:
Study ID Numbers:  CDR0000068017;  NCI-102,SUMC-NCI-102
Study Start Date: April 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006009

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2. Donor Stem Cell Transplantation in Treating Patients With Relapsed Hematologic Cancer

3. Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

4. Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation

5. Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis

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