Non Hodgkin Lymphoma Clinical Trial
Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma
Summary
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.
Full Description
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 Criteria
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
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There is 1 Location for this study
Bethesda Maryland, 20892, United States
Bethesda Maryland, 20892, United States
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