Back to resultsCombination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma
Primary Purpose
Lymphoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
denileukin diftitox
cyclophosphamide
cytarabine
doxorubicin hydrochloride
leucovorin calcium
methotrexate
prednisone
vincristine sulfate
protein expression analysis
flow cytometry
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility 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
Sites / Locations
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Outcomes
Primary Outcome Measures
Failure-free survival
Secondary Outcome Measures
Response rate (CR, CRu, and PR)
Overall survival
Toxicity profile
Correlation of response with CD25 expression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00513188
Brief Title
Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma
Official Title
A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
denileukin diftitox
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Failure-free survival
Secondary Outcome Measure Information:
Title
Response rate (CR, CRu, and PR)
Title
Overall survival
Title
Toxicity profile
Title
Correlation of response with CD25 expression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maricer Escalon, MD, MS
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma
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