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Monoclonal Antibody hA20 in Treating Patients With Refractory Non-Hodgkin''s Lymphoma - Article


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Wegener's Granulomatosis

Wegener Granulomatosis


Clinical Trial: Monoclonal Antibody hA20 in Treating Patients With Refractory Non-Hodgkin''s Lymphoma

This study is currently recruiting patients.

Sponsored by: Immunomedics, Inc.
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies, such as hA20, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody hA20 in treating patients with refractory B-cell non-Hodgkin''''s lymphoma.

Condition Treatment or Intervention Phase
adult lymphomatoid granulomatosis
adult non-Hodgkin''''s lymphoma
indolent or aggressive adult non-Hodgkin''''s lymphoma
 Drug: monoclonal antibody hA20
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: monoclonal antibody therapy
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Monoclonal Antibody hA20 in Patients With Refractory CD20-Positive Follicular B-Cell Non-Hodgkin''''s Lymphoma

Further Study Details: 

OBJECTIVES: Primary

  • Determine the safety and tolerability of monoclonal antibody hA20 in patients with refractory CD20-positive follicular B-cell non-Hodgkin''''s lymphoma.
  • Determine the immunogenicity of this drug in these patients.

Secondary

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive monoclonal antibody hA20 IV once weekly for 4 weeks.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody hA20 until the optimal dose is determined. Up to 10 additional patients are treated at the optimal dose.

After completion of study treatment, patients are followed weekly for 4 weeks, at 8 and 12 weeks, and then every 3 months until disease progression.

PROJECTED ACCRUAL: Approximately 19-28 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • Over 18

Performance status

  • ECOG 0-1 OR
  • Karnofsky 80-100%

Life expectancy

  • At least 6 months

Hematopoietic

  • Hemoglobin > 10 g/dL*
  • Absolute neutrophil count > 1,500/mm^3*
  • Platelet count > 100,000/mm^3* NOTE: *Transfusion independent

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2.5 times ULN

Renal

  • Creatinine < 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy

  • See Disease Characteristics
  • At least 12 months since prior rituximab

Chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

Surgery


Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00112970


New York
      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
John P. Leonard, MD  973-605-8200 ext. 182    jpleonard@med.cornell.edu 

      St. Luke''''s-Roosevelt Hospital Center - Roosevelt Division, New York,  New York,  10019,  United States; Recruiting
Michael L. Grossbard, MD  973-605-8200 ext. 182    mgrossbard@chpnet.org 

Study chairs or principal investigators

William A. Wegener, MD, PhD,  Study Chair,  Immunomedics, Inc.   

More Information

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

Study ID Numbers:  CDR0000425383; IM-T-HA20-01
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112970
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07


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October 8, 2008



Page Updated: October 3, 2005
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