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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00513188
First received: August 6, 2007
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Lymphoma
 Biological: denileukin diftitox
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: methotrexate
Drug: prednisone
Drug: vincristine sulfate
Genetic: protein expression analysis
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Failure-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (CR, CRu, and PR) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity profile [ Designated as safety issue: Yes ]
  • Correlation of response with CD25 expression [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513188

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Maricer Escalon, MD, MS University of Miami Sylvester Comprehensive Cancer Center
  More Information

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

No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00513188     History of Changes
Other Study ID Numbers: EPROST-20060912, SCCC-2006068
Study First Received: August 6, 2007
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
adult nasal type extranodal NK/T-cell lymphoma
stage IV mycosis fungoides/Sezary syndrome
stage IV cutaneous T-cell non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Methotrexate
Denileukin diftitox
Doxorubicin
 Prednisone
Vincristine
Interleukin-2
Leucovorin
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013