Clinical Trial: Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: Parker Hughes Institute
Information provided by: National Cancer Institute (NCI)

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 I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent acute lymphoblastic leukemia or non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent adult diffuse large cell lymphoma
recurrent childhood large cell lymphoma
recurrent adult acute lymphoblastic leukemia
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
recurrent childhood acute lymphoblastic leukemia
 Drug: B43-genistein immunoconjugate
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of B43-Genistein Immunoconjugate in Patients With Recurrent B-cell Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: March 2000

OBJECTIVES: I. Determine the maximum tolerated dose of B43-genistein immunoconjugate in patients with recurrent B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma. II. Determine the systemic B43-genistein exposure levels in these patients. III. Determine the antileukemic activity of this regimen in these patients. IV. Monitor the development of human antimouse antibody in these patients on this regimen.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive B43-genistein immunoconjugate IV over 1 hour on days 1-3, 8-10, and 15-17. Treatment continues every 3 weeks in the absence of unacceptable toxicity or until disease progression. Cohorts of 3-6 patients receive escalating doses of B43-genistein immunoconjugate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 6 months.

PROJECTED ACCRUAL: A minimum of 3-15 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  up to  80 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: See Disease Characteristics; Recovered from prior biologic therapy
  • Chemotherapy: See Disease Charactertistics; At least 2 weeks since prior chemotherapy (4 weeks since nitrosoureas) and recovered
  • Endocrine therapy: At least 1 week since prior high dose steroid therapy and recovered
  • Radiotherapy: Not specified
  • Surgery: Not specified

--Patient Characteristics--

  • Age: 80 and under
  • Performance status: Karnofsky 60-100%; Zubrod 0-2
  • Life expectancy: At least 2 months
  • Hematopoietic: Granulocytopenia, anemia, and/or thrombocytopenia allowed
  • Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT less than 2.5 times ULN
  • Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance or radioisotope GFR at least 70 mL/min
  • Cardiovascular: Shortening fraction at least 27% by echocardiogram OR Cardiac ejection fraction greater than 50% by echocardiogram or gaited radionuclide
  • Pulmonary: No dyspnea at rest No exercise intolerance; No clinical evidence of significant restrictive pulmonary disease; Pulse oximetry greater than 94%; FEV1 or FVC greater than 60% DLCO at least 65
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 2 months after study; HIV negative; No uncontrolled diabetes mellitus; No other serious uncontrolled medical condition; No active uncontrolled infection requiring systemic antibiotics or antifungal medications; Prior CNS toxicity no greater than grade 1

Location Information


California
      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States

District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States

Minnesota
      Parker Hughes Institute, St. Paul,  Minnesota,  55113,  United States

Study chairs or principal investigators

Fatih M. Uckun,  Study Chair,  Parker Hughes Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067509; HUGHES-PHBC-18; NCI-V00-1583; HUGHES-IRB-9810018
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004858
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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