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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00513188
• Other study ID #: 20060912
• Secondary ID: SCCC-2006068
• Status: Withdrawn
• Phase: N/A
• First received: August 6, 2007
• Last updated: December 14, 2016
• Start date: February 2007

Study information

• Verified date: December 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

Biological:
• denileukin diftitox

Drug:
• cyclophosphamide

• cytarabine

• doxorubicin hydrochloride

• leucovorin calcium

• methotrexate

• prednisone

• vincristine sulfate

Genetic:
• protein expression analysis

Other:
• flow cytometry

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival			No
Secondary	Response rate (CR, CRu, and PR)			No
Secondary	Overall survival			No
Secondary	Toxicity profile			Yes
Secondary	Correlation of response with CD25 expression			No