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


N/A
18 Years
65 Years
Not Enrolling
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Failure-free survival

Safety Issue:

No

Principal Investigator

Maricer Escalon, MD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20060912

NCT ID:

NCT00513188

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136