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Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00014664
Recruitment Status : Unknown
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 10, 2003
Last Update Posted : December 18, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 10, 2001
First Posted Date  ICMJE June 10, 2003
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE October 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title  ICMJE A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)
Brief Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

  • Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in patients with relapsed or refractory grade I, II, or III B-cell non-Hodgkin's lymphoma.
  • Compare the preliminary tumor response and progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive monoclonal antibody (MOAB) Hu1D10 IV over approximately 2 hours on days 1, 8, 15, and 22.
  • Arm II: Patients receive MOAB Hu1D10 as in arm I at a higher dose.
  • Arm III:Patients receive MOAB Hu1D10 IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.

Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 1, 4, and 12 and then at months 6, 9, 12, 18, and 24.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Biological: apolizumab
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed relapsed or refractory grade I, II, or III non-Hodgkin's lymphoma (NHL), including follicular, small lymphocytic, or marginal zone/MALT lymphoma
  • Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL

    • Progression of disease or no response since last treatment for NHL
  • 1D10+ lymphoma by immunohistochemistry or flow cytometry
  • Bidimensionally measurable disease at least 2 cm in a single dimension
  • No CNS metastases
  • Circulating tumor cells no greater than 5,000/mm^3

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Platelet count at least 75,000/mm^3 (unless disease related)
  • Neutrophil count at least 1,000/mm^3 (unless disease related)
  • Hemoglobin greater than 8.0 g/dL

Hepatic:

  • Bilirubin less than 2.5 mg/dL
  • SGOT less than 4 times upper limit of normal

Renal:

  • Creatinine less than 2.5 mg/dL

Cardiovascular:

  • No clinically significant cardiac disease (New York Heart Association class III or IV)
  • No evidence of myocardial infarction or cardiac arrhythmia (unless surgically repaired) within the past 6 months

Pulmonary:

  • No clinically significant pulmonary disease

Other:

  • No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ
  • No significant psychiatric or CNS impairment
  • No active serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study
  • Negative anti-Hu1D10 antibody response (HAHA/HAMA)
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior interferon therapy
  • At least 3 months since prior immunotherapy
  • No prior monoclonal antibody Hu1D10

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior corticosteroids (more than 10 mg prednisone/day)
  • No concurrent corticosteroids at more than 10 mg prednisone/day for pre-existing diseases or adverse reactions

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior external beam radiotherapy
  • At least 3 months since prior radioimmunotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent lymphoma therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00014664
Other Study ID Numbers  ICMJE CDR0000068585
PDL-1D10-901
CUMC-0101-552
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE PDL BioPharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Tillman Pearce, MD Facet Biotech
PRS Account National Cancer Institute (NCI)
Verification Date September 2002

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