A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma

Inclusion 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