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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Cyclophosphamide; Cytarabine; Denileukin diftitox; Doxorubicin; Interleukin-2; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Methotrexate; Prednisone; Vincristine

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