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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)

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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: apolizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2000






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014664


Locations
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United States, California
Protein Design Labs, Inc.
Freemont, California, United States, 94555
Sponsors and Collaborators
PDL BioPharma, Inc.
Investigators
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Study Chair: Tillman Pearce, MD Facet Biotech
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ClinicalTrials.gov Identifier: NCT00014664    
Other Study ID Numbers: CDR0000068585
PDL-1D10-901
CUMC-0101-552
First Posted: June 10, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: September 2002
Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases