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Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: April 10, 2001   Last Updated: February 6, 2009   History of Changes
Sponsored by: PDL BioPharma, Inc.
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014664
  Purpose

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 Intervention Phase
Lymphoma
Biological: apolizumab
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014664

Locations
United States, California
Protein Design Labs, Inc.
Freemont, California, United States, 94555
Sponsors and Collaborators
PDL BioPharma, Inc.
Investigators
Study Chair: Tillman Pearce, MD Facet Biotech
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068585, PDL-1D10-901, CUMC-0101-552
Study First Received: April 10, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00014664     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Immunoproliferative Disorders
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Follicular Lymphoma
Recurrence
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Antibodies
Chronic Lymphocytic Leukemia
B-cell Lymphomas
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on August 25, 2009