Expired Study
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Los Angeles, California 90095


RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry cancer-killing substances directly to non-Hodgkin's lymphoma cells. PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Study summary:

OBJECTIVES: Primary - Determine the efficacy of denileukin diftitox, in terms of objective response and time to progression, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Secondary - Determine the safety of this drug in these patients. - Determine the 1-year overall survival of patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive denileukin diftitox IV over 20-80 minutes on days 1-3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, and 99 (weeks 1-16) in the absence of disease progression or unacceptable toxicity. Patients achieving a partial response at week 16 may continue treatment once monthly for up to 8 additional doses or until a complete response (CR) is achieved. Patients achieving a CR (at any time) receive 2 additional monthly doses of denileukin diftitox beyond CR. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.


DISEASE CHARACTERISTICS: - Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following subtypes: - Diffuse large B-cell lymphoma - Follicular lymphoma (grades 1-3) - Small lymphocytic lymphoma - Transformed B-cell lymphoma - Relapsed or refractory disease - Disease failed to respond to or progressed after ≥ 2 prior treatment regimens (e.g., high-dose therapy [HDT] with stem cell transplantation [SCT]*) NOTE: *Patients who have received HDT with SCT are considered to have diminished bone marrow reserve - Diminished bone marrow reserve AND/OR mild to moderate cytopenia, meeting 1 of the following criteria: - Absolute neutrophil count ≥ 1,000/mm^3 but < 1,500/mm^3 (growth factor independent) - WBC ≥ 2,000/mm^3 but < 4,000/mm^3 (growth factor independent) - Platelet count ≥ 40,000/mm^3 (25,000/mm^3 if thrombocytopenia is secondary to marrow involvement by lymphoma) but < 150,000/mm^3 (platelet transfusion independent) - At least 1 bidimensionally measurable lymph node or tumor mass ≥ 4 cm PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 16 weeks Hematopoietic - See Disease Characteristics Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 2 times ULN - Albumin ≥ 3.0 g/dL - No history of veno-occlusive disease of the liver - No chronic hepatitis Renal - Creatinine < 2 times ULN Cardiovascular - No congestive heart failure - No New York Heart Association class III-IV cardiac disease - No ventricular tachycardia - No fibrillation - No myocardial infarction within the past 12 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV positivity - No active GVHD ≥ grade 2 within the past 6 months - No other serious medical illness or active infection that would preclude study participation - No known hypersensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or their excipients) - No other malignancy within the past 5 years except successfully treated carcinoma in situ of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 6 months since prior allogeneic SCT - No concurrent immunotherapy Chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent anticancer hormonal therapy - No concurrent corticosteroids for the treatment of NHL - Concurrent corticosteroids allowed for the following conditions: - Tapering doses of corticosteroids for resolving graft-versus-host disease (GVHD) - Low-dose maintenance corticosteroids for the treatment of an autoimmune disorder - Corticosteroids as premedication prior to denileukin diftitox administration or as transient treatment for hypersensitivity reactions Radiotherapy - More than 4 weeks since prior and no concurrent radiotherapy - No prior radiotherapy to the only site of evaluable disease unless disease progression has occurred at that site Surgery - Not specified Other - At least 3 weeks since prior antilymphoma therapy - More than 4 weeks since prior and no other concurrent experimental therapy, including approved drugs tested in an investigational setting



Primary Contact:

Principal Investigator
Lauren C. Pinter-Brown, MD
Jonsson Comprehensive Cancer Center

Backup Contact:


Location Contact:

Los Angeles, California 90095
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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