Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma (NCT00003615) | Clinical Trial Compass
CompletedPhase 2
Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
United States77 participantsStarted 1999-05-20
Plain-language summary
RATIONALE: Immunotoxins such as denileukin diftitox can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkin's lymphoma that has not responded to previous treatment.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS: Histologically proven stage I, II, III, or IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma Small lymphocytic Follicular small cleaved cell Follicular mixed cell Follicular large cell Marginal Diffuse large B-cell Lymphoplasmacytoid Patients with small lymphocytic lymphoma must have an absolute lymphocyte count less than 10,000/mm3 At least one bidimensionally measurable site At least 1.5 cm in its greatest dimension Not in field of prior radiotherapy Progressive disease after at least one prior treatment regimen for lymphoma 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: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Absolute neutrophil count at least 1000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT or AST no greater than 2 times ULN Albumin greater than 3.0 g/dL No hepatitis B or C infection Renal: Creatinine no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection requiring anti-infective therapy No other prior invasive malignancy within …