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Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003615
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: denileukin diftitox
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Interleukin-2 Denileukin diftitox
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of DAB 389 IL-2, an Interleukin-2 Fusion Toxin, for Previously Treated Stage II, III, and IV Follicular Low-Grade Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 77
Study Start Date: March 1999
Detailed Description:

OBJECTIVES: I. Determine the objective response rate in patients with previously treated stage I, II, III, or IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma treated with denileukin diftitox. II. Determine the time to progression, duration of remission, and time to treatment failure in patients after treatment with this therapy. III. Determine the toxicity of this therapy in these patients. IV. Correlate the results of the inteleukin-2 receptor assay with treatment outcomes in these patients.

OUTLINE: Patients are stratified according to interleukin-2 receptor classification (positive vs negative). Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment repeats every 21 days for 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for the interleukin-2 (IL-2) receptor-positive stratum and a total of 11-44 patients will be accrued for the IL-2 receptor-negative stratum.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 past 5 years, except: Curatively treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior stem cell transplantation allowed At least 4 weeks since prior biologic therapy No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent hormonal therapy (except contraceptives and replacement steroids) No concurrent corticosteroids Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy for localized disease No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental medications (including approved drugs tested in an investigational setting)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003615

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States, 08822
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Overlook Hospital
Summit, New Jersey, United States, 07902-0220
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, United States, 07701
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000066692, E-1497
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003615  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage I adult diffuse large cell lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse large cell lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse large cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse large cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Recurrence
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Interleukin-2
Leukemia, Lymphocytic, Chronic, B-Cell
Denileukin diftitox
B-cell lymphomas
Waldenstrom macroglobulinemia
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009