Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theradex
• Treatments: Cisplatin; Cytarabine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Pixantrone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following:

• Diffuse large B-cell lymphoma

• Transformed NHL

• Follicular large cell lymphoma

• Peripheral T-cell lymphoma

• Unclassified aggressive histology (immunoblastic lymphoma)

• Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m^2)

• No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 to 64

Performance status

• WHO 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Neutrophil count at least 1,500/mm^3*

• Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if evidence of bone marrow involvement

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)**

• Alkaline phosphatase no greater than 2 times ULN**

• AST or ALT no greater than 2 times ULN**

• No history or clinical symptoms of hepatitis B or C virus NOTE: **Higher values may be accepted if evidence of liver involvement

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• LVEF at least 50% by MUGA

• No clinically significant cardiovascular abnormalities

• No New York Heart Association class II-IV heart disease

• No myocardial infarction within the past 6 months

• No severe arrhythmia

• No uncontrolled hypertension

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 6 months after study

• No history or clinical symptoms of HIV

• No clinically significant neurological abnormalities

• No serious uncontrolled infection (NCI CTC grade 3-4)

• No condition that would place the patient at undue risk or interfere with the study results

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 months since prior radioimmunotherapy

Chemotherapy

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy

• At least 1 year since prior platinum or cytarabine (unless complete response to treatment)

• At least 2 years since prior fludarabine or nitrosoureas

• No prior cumulative cisplatin greater than 600 mg/m^2

Endocrine therapy

• Not specified

Radiotherapy

• See Biologic therapy

• At least 4 weeks since prior radiotherapy

• No prior radiotherapy to the whole pelvis

Surgery

• At least 1 week since prior minor surgery and recovered

• At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered

Other

• At least 1 month since prior investigational drugs

• Recovered from prior therapy

• No other concurrent investigational drugs