Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Los Angeles, California 90095


Purpose:

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.


Criteria:

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


NCT ID:

NCT00138164


Primary Contact:

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


Backup Contact:

N/A


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: December 16, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.