Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma
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Purpose
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent or refractory lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: monoclonal antibody mono-dgA-RFB4 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma |
| Study Start Date: | November 2000 |
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen.
- Determine the pharmacokinetic profile of this drug in these patients.
- Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of this drug in these patients.
- Determine whether clinical responses in these patients occur at lower, equal, or higher doses than historical responses induced by a similar drug.
OUTLINE: This is a dose-escalation study. Patients are stratified according to number of circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less).
Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5. Patients achieving complete, partial, or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients achieving complete remission or stable partial remission are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or refractory B-cell lymphoma after at least 1 standard chemotherapy regimen
- Low, intermediate, or high grade
- CD22 antigen on at least 30% of tumor cells by flow cytometry
- No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell acute lymphocytic leukemia, or hairy cell leukemia
Measurable disease
- Positive bone marrow not considered measurable
- Circulating tumor cells in peripheral blood considered measurable
- No CNS disease (leptomeningeal or parenchymal)
- No lymphomatous or infectious pulmonary parenchymal disease
- No baseline/pleural effusion
- Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count greater than 50,000/mm^3
- Absolute granulocyte count greater than 750/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- SGPT less than 2 times upper limit of normal
- Albumin greater than 75% lower limit of normal
Renal:
- Creatinine no greater than 1.4 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- Ejection fraction greater than 40% by MUGA or echocardiogram
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL
- No condition that may require stenting of ureters, stabilization of impending pathological fractures, or relief of airway, bowel, or biliary tract obstruction
- No other concurrent illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
- At least 2 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroids unless receiving stable maintenance dose prior to therapy
Radiotherapy:
- No prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational agents
Contacts and Locations| United States, Maryland | |
| Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Edward A. Sausville, MD, PhD | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00007956 History of Changes |
| Obsolete Identifiers: | NCT00006423 |
| Other Study ID Numbers: | CDR0000068356, NCI-01-C-0021, UTSMC-99-02-07 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 6, 2009 |
| 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 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 Burkitt lymphoma recurrent mantle cell lymphoma recurrent small lymphocytic lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013