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

NCT00513188 | Withdrawn DMC

• 2 other identifiers: 20060912SCCC-2006068
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

Secondary Outcomes (4)

• Response rate (CR, CRu, and PR)

• Overall survival

• Toxicity profile

• Correlation of response with CD25 expression

Interventions

denileukin diftitox BIOLOGICAL

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

leucovorin calcium DRUG

methotrexate DRUG

prednisone DRUG

vincristine sulfate DRUG

protein expression analysis GENETIC

flow cytometry OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Lymphoma; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Extranodal NK-T-Cell; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Interventions

denileukin diftitox; Cyclophosphamide; Cytarabine; Doxorubicin; Leucovorin; Methotrexate; Prednisone; Vincristine; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Maricer Escalon, MD, MS

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2008
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)