Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma

December 14, 2016 updated by: University of Miami

A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to non-Hodgkin lymphoma cells. Giving combination chemotherapy together with denileukin diftitox may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with denileukin diftitox works in treating patients with newly diagnosed T-cell non-Hodgkin lymphoma.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate failure-free survival of patients with newly diagnosed peripheral T-cell non-Hodgkin lymphoma treated with cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone (CHOP), and denileukin diftitox (Ontak®) alternating with high-dose methotrexate, leucovorin calcium, cytarabine, and Ontak® (CHOP-MONTAK regimen).

Secondary

  • To determine the response rate (CR, CRu, and PR) in these patients.
  • To determine the overall survival of these patients.
  • To determine the toxicity profile of this regimen.
  • To correlate response with CD25 expression in these patients.

OUTLINE:

  • Courses 1, 3, and 5: Patients receive cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1; oral prednisone once daily on days 1-5; and denileukin diftitox IV over 60 minutes on days 1 and 2. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Courses 2, 4, and 6: Patients receive high-dose methotrexate (MTX) IV over 24 hours on day 1; cytarabine IV over 2 hours every 12 hours on days 2 and 3; and leucovorin calcium IV over 15 minutes every 6 hours for 8 doses beginning 12 hours after the last dose of each MTX infusion. Patients also receive denileukin diftitox IV over 60 minutes for 2 doses once MTX blood levels have cleared. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Samples are analyzed for CD25-positive or -negative expression and response rate via flow cytometry.

After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Study Type

Interventional

Phase

  • Not Applicable

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
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of peripheral T-cell non-Hodgkin lymphoma

    • Newly diagnosed, previously untreated disease
    • Mycosis fungoides with systemic disease (i.e., beyond the skin) allowed
  • No CD30-positive ALK 1-positive T-anaplastic large cell lymphoma
  • No skin only involvement
  • No localized NK/T-cell lymphoma
  • No adult T-cell leukemia/lymphoma
  • No known CNS involvement

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC > 1,000/mm^3 (unless due to lymphoma)
  • Platelets > 100,000/mm^3 (unless due to lymphoma)
  • Serum bilirubin ≤ 2.0 mg/dL (unless due to lymphoma)
  • Serum creatinine ≤ 1.5 mg/dL (unless due to lymphoma)
  • Albumin ≥ 3.0 g/dL
  • Cardiac ejection fraction ≥ 50% by MUGA or echocardiogram
  • Not pregnant or nursing
  • Negative serum or urine β-HCG at screening
  • Women and male partners of child-bearing potential must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before study entry and throughout the study period
  • Willing to receive transfusions of blood products
  • No HIV-positive serology

  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Child's class C liver cirrhosis
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situations that would limit study compliance
  • No other prior or concurrent malignancy with a poor prognosis (i.e., < 90% probability of survival at 5 years) or that is actively being treated

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for the treatment of lymphoma
  • No other concurrent investigational agents for the treatment of lymphoma

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Failure-free survival

Secondary Outcome Measures

Outcome Measure
Overall survival
Toxicity profile
Response rate (CR, CRu, and PR)
Correlation of response with CD25 expression

Collaborators and Investigators

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

Sponsor

University of Miami

Investigators

  • Study Chair: Maricer Escalon, MD, MS, University of Miami Sylvester Comprehensive Cancer Center

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

February 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (Estimate)

August 8, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060912
  • SCCC-2006068

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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