Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse

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

Summary

RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in 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 II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)

• Any stage, with or without B symptoms

• The following subtypes are eligible:

• Diffuse large cell (B and T cell types)

• Anaplastic large cell

• Diffuse mixed cell

• Immunoblastic large cell

• Follicular large cell

• Transformed follicular NHL

• Diffuse aggressive not otherwise classified

• Burkitt-like lymphoma

• Bone marrow positive or negative

• At least 1 measurable lesion

• Patients with bone marrow as the only site of disease are eligible without a measurable lesion

• No more than 1 episode of progressive disease, occurring after a response (complete response [CR], complete response unconfirmed [CR_u], or partial response [PR]) to prior chemotherapy* NOTE: *Patients with less than a CR, CRu, or PR and no progression, but who are good candidates for high-dose chemotherapy with stem cell support may be eligible (will be decided on an individual basis)

• No chemotherapy-refractory disease, defined as follows:

• Stable or progressive disease documented at restaging immediately after the completion of induction therapy

• No lymphoblastic lymphoma, or mantle cell lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

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 clearly due to bone marrow involvement by lymphoma

Hepatic

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

• AST or ALT no greater than 2.0 times ULN*

• Alkaline phosphatase no greater than 2.0 times ULN*

• No history or clinical symptoms of hepatitis B or hepatitis C virus

• Patients with seropositivity due to prior vaccination for hepatitis B are eligible NOTE: *Higher values may be accepted if clearly due to liver involvement by lymphoma

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 grade II-IV cardiovascular disease

• No myocardial infarction within the past 6 months

• No severe cardiac arrhythmia

• No uncontrolled hypertension

Other

• Not pregnant or nursing

• Negative pregnancy test

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

• HIV negative

• No clinically significant neurological abnormalities

• No condition that would preclude study safety or interfere with study results

• No concurrent serious uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior rituximab immediately after the first chemotherapy regimen allowed

Chemotherapy

• See Disease Characteristics

• See Biologic therapy

• At least 6 months since prior anthracycline therapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP])

• More than 2 years since prior fludarabine

• More than 2 years since prior nitrosoureas

• More than 1 year since prior platinum-based chemotherapy or cytarabine, unless a CR or CR_u was achieved

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

• No prior single or cumulative dose of doxorubicin greater than 450 mg/m^2

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to the whole pelvis

• No prior radioimmunotherapy

Surgery

• More than 4 weeks since prior major thoracic and/or abdominal surgery

• At least 1 week since prior minor surgery

Other

• Recovered from prior therapy

• Alopecia allowed

• Grade 1 peripheral neuropathy allowed

• More than 30 days since prior participation in another investigational drug study

• No other concurrent investigational drugs