Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT00138164 | Completed Phase 2

• 3 other identifiers: LIGAND-PIND-123UCLA-0412087-01CDR0000439451
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective clinical response (complete or partial response)

Secondary Outcomes (3)

• Time to progression

• Overall survival at 1 year

• Safety

Interventions

denileukin diftitox BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren C. Pinter-Brown, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: December 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: November 1, 2008
• Last Updated: May 30, 2013

Record last verified: 2008-11

Locations

US (1)