Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: apolizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL) |
| Enrollment: | 35 |
| Study Start Date: | November 1999 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Biological: apolizumab |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231 | |
| Biologics Evaluation Section | |
| Bethesda, Maryland, United States, 20892-9903 | |
| United States, New York | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| Study Chair: | Brian Link, MD | Holden Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004101 History of Changes |
| Other Study ID Numbers: | CDR0000067318, UIHC-UICC-LW-02, NCI-T99-0019 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013