Status:
COMPLETED
Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 wel...
Detailed Description
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. S...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00138164
Start Date
December 1 2004
End Date
November 1 2008
Last Update
May 30 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781