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)
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Sponsors
Source
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.
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.
Overall Status
Unknown status
Start Date
2000-10-01
Completion Date
N/A
Primary Completion Date
N/A
Phase
Phase 2
Study Type
Interventional
Condition
Intervention
Eligibility
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Tillman Pearce, MD |
Study Chair |
Facet Biotech |
Location
Facility |
|
Protein Design Labs, Inc. Freemont California 94555 United States |
Location Countries
Country
United States
Verification Date
2002-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
PDL-1D10-901
CUMC-0101-552
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Primary Purpose
Treatment
Study First Submitted
April 10, 2001
Study First Submitted Qc
June 9, 2003
Study First Posted
June 10, 2003
Last Update Submitted
December 17, 2013
Last Update Submitted Qc
December 17, 2013
Last Update Posted
December 18, 2013
Last Known Status
Active, not recruiting
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
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conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.