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Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004101
First received: December 10, 1999
Last updated: February 8, 2013
Last verified: May 2001

December 10, 1999
February 8, 2013
November 1999
June 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00004101 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)

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

OBJECTIVES:

I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.

II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.

III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients.

IV. Evaluate any antilymphoma effects of this drug in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.

Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease progression.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Biological: apolizumab
Experimental: Arm I
Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.
Intervention: Biological: apolizumab
Link BK, Wang H, Byrd JC, et al.: Phase I trial of humanized 1D10 (Hu1D10) monoclonal anitbody class II molecules in patients with relapsed lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A86, 2000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
Not Provided
June 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior treatment
  • At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR at least 50% of B cells within tumor reactive with 1D10 if extensive T cell infiltrations present
  • Measurable or evaluable disease
  • Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only)
  • Not eligible for curative conventional therapy

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: ECOG 0-2
  • Life expectancy: At least 3 months
  • Platelet count at least 75,000/mm3
  • Bilirubin less than 2.5 mg/dL
  • SGOT less than 3 times upper limit of normal
  • Creatinine less than 2.0 mg/dL
  • No New York Heart Association class III or IV heart disease
  • No clinically significant pulmonary disease
  • No active serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior interferon
  • Concurrent transfusions allowed
  • At least 4 weeks since prior cytotoxic chemotherapy
  • No concurrent antineoplastic agents
  • At least 4 weeks since prior corticosteroids
  • No concurrent glucocorticoids
  • At least 4 weeks since prior radiotherapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004101
CDR0000067318, UIHC-UICC-LW-02, NCI-T99-0019
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Brian Link, MD Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP