Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: bispecific antibody 4G7xH22 Biological: sargramostim |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL) |
| Study Start Date: | September 2000 |
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Assess the clinical toxicity of this antibody in these patients.
OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22.
Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1 year.
PROJECTED ACCRUAL: Approximately 18 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 |
DISEASE CHARACTERISTICS:
Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia
- Primary refractory or multiply relapsed (after at least 2 prior chemotherapy regimens) disease
- Ineligible for bone marrow or peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Absolute neutrophil count greater than 1,500/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- Alkaline phosphatase less than 2 times normal
- SGPT less than 2 times normal
Renal:
- Creatinine clearance greater than 50 mL/min
Other:
- No human-anti-murine-antibody response to prior murine monoclonal antibodies
- No immunological or inflammatory disease (e.g., lupus erythematosus)
- No active serious infection
- No other serious medical condition that would limit survival to less than 2 years
- No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
- No psychiatric or addictive disorder that would preclude study
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior immunotherapy allowed
Chemotherapy:
- See Disease Characteristics
- No concurrent chemotherapy
Endocrine therapy:
- Concurrent steroids for adrenal failure or adverse reactions to study drug allowed
- Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Study Chair: | Pamela Ely, MD | Norris Cotton Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00014560 History of Changes |
| Other Study ID Numbers: | CDR0000068556, DMS-9806, NCI-G01-1936 |
| Study First Received: | April 10, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
refractory chronic lymphocytic leukemia 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 small lymphocytic lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Immunoglobulins Antibodies, Bispecific Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013