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

December 17, 2013 updated by: Pharmatech Oncology

A Multicenter Phase II Evaluation Of ONTAK (DENILEUKINDIFTITOX) In Patients With Low Or Intermediate Grade-B-Cell Non-Hodgkin's Lymphoma Who Have Been Treated Previously With A Monoclonal Antibody Or Who Are Not Candidates For Monoclonal Antibody Therapy

RATIONALE: Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to non-Hodgkin's lymphoma cells.

PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkin's lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the efficacy of denileukin diftitox in patients with stages I-IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma. II. Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study. Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may receive up to 2 additional courses after achieving complete response. Patients are followed every 3 months until they have progressed or for 2 years from date of termination.

PROJECTED ACCRUAL: A total of 58 patients (29 with low-grade non-Hodgkin's lymphoma (NHL) and 29 with intermediate-grade NHL) will be accrued for this study within 12 months. The study may be stopped after accrual of 20 patients (10 with low-grade NHL and 10 with intermediate-grade NHL) if observed response rate is less than 1 in 10 for each stratum.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pomona, California, United States, 91767
        • ION/Pharmatech Network
      • Rancho Mirage, California, United States, 92270
        • Cancer and Blood Institute of the Desert
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Missouri Cancer Care, P.C.
    • New York
      • Lake Success, New York, United States, 11042
        • Nassau Hematology/Oncology PC
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Coastal Cancer Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed low-grade B-cell non-Hodgkin's lymphoma (NHL) Working Formulation classification: Small lymphocytic lymphoma Follicular lymphoma (small cleaved or mixed small and large cell) REAL classification: B-cell chronic lymphocytic leukemia/small lymphocytic Lymphoplasmacytoid Marginal zone/MALT Follicular small or mixed small and large cell OR Histologically confirmed intermediate-grade B-cell NHL Working Formulation classification: Follicular large cell Diffuse small cleaved cell Diffuse mixed small and large cell Diffuse large cell REAL classification: Mantle cell Diffuse small cell Marginal zone/MALT Large B-cell Lymphoplasmacytoid Stage I, II, III, or IV disease No cutaneous T-cell lymphoma or other T-cell NHL Bidimensionally measurable disease Unidimensionally measurable disease allowed for mediastinal lymphoma only if outside previously irradiated field or there is evidence of progression Received prior monoclonal antibody therapy OR ineligible for monoclonal antibody therapy 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: Absolute neutrophil count at least 1,000/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) AST and ALT no greater than 1.5 times ULN Albumin at least 3.0 g/dL No chronic hepatitis Renal: Creatinine less than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No poorly controlled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious concurrent illness or active infection requiring parenteral antibiotics that would preclude study No known hypersensitivity to study drug or its components, including diphtheria toxin, interleukin-2, or excipients No other malignancy within the past 5 years except resected basal or squamous cell skin cancer or carcinoma in situ of the cervix (prostate cancer in situ or breast cancer in situ within the past 5 years is allowed if patients are in complete remission with no active disease, have stable tumor markers for at least 3 months, and have a life expectancy of at least 2 years)

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior bone marrow transplantation allowed No prior denileukin diftitox or DAB486 IL-2 No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent hormonal anticancer therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to sole site of disease unless evidence of progression No concurrent radiotherapy Surgery: Not specified Other: At least 1 month since prior investigational agent No other concurrent experimental medications, including approved drugs tested in an investigational setting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmatech Oncology

Investigators

  • Study Chair: Debby Henkens, Pharmatech Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Registration Dates

First Submitted

November 9, 2001

First Submitted That Met QC Criteria

February 26, 2004

First Posted (Estimate)

February 27, 2004

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

February 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069029
  • PHARMATECH-LP-ONT-BL
  • LIGAND-PHARMATECH-LP-ONT-BL
  • PHARMATECH-20002024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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