Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin’s Lymphoma (NHL)

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced aggressive non-Hodgkin's lymphoma (NHL), including any of the following subtypes:

B-cell NHL, including any of the following subtypes:

Diffuse large B-cell lymphoma
Primary mediastinal (thymic) B-cell lymphoma
Intravascular large B-cell lymphoma
Immunoblastic B-cell lymphoma
Mantle cell lymphoma
Burkitt's lymphoma
Follicular grade 3b lymphoma

T-cell NHL, including any of the following subtypes:

Anaplastic large cell lymphoma
Peripheral T-cell lymphoma, not otherwise specified
De novo or transformed disease

Refractory (i.e., disease not amenable to standard therapy) or relapsed disease, as evidenced by 1 of the following:

Refractory to OR relapsed after ≥ 1 prior combination chemotherapy regimen
Refractory to OR relapsed after prior CD20-based immunotherapy (for patients eligible to receive such therapy)
Refractory after prior high-dose chemotherapy and autologous stem cell transplantation AND ≥ 100 days post transplantation
At least 1 bidimensionally measurable lesion ≥ 1.5 cm by CT scan, MRI, x-ray, or clinical examination
No active CNS lymphoma

PATIENT CHARACTERISTICS:

Performance status

ECOG 0-2

Life expectancy

At least 3 months

Hematopoietic

Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 9 g/dL
No known coagulopathy

Hepatic

ALT and/or AST ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic lymphoma)
Bilirubin ≤ 1.5 times ULN

Renal

Creatinine ≤ 2.0 mg/dL

Immunologic

No known HIV infection
No serious active infection that requires IV antibiotics or antifungal or antiviral agents

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-method contraception during and for 1 year after completion of study treatment
No known or suspected alcohol or drug abuse
No sensory or motor neuropathy ≥ grade 3
No other malignancy within the past 5 years except nonmelanoma skin cancer
No other life-threatening illness or organ dysfunction that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
See Radiotherapy
More than 3 weeks since prior and no concurrent immunotherapy
No prior allogeneic bone marrow transplantation

Chemotherapy

See Disease Characteristics
More than 3 weeks since prior and no concurrent chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

No concurrent hormonal therapy

Radiotherapy

No prior radiotherapy to the only site of measurable disease unless there is documented disease progression after completion of radiotherapy
More than 8 weeks since prior and no concurrent systemic radioimmunotherapy

More than 3 weeks since prior and no concurrent radiotherapy

Concurrent palliative radiotherapy to sites other than the only measurable target lesion allowed for symptom control provided the reason for radiotherapy does not reflect progressive disease

Other

No concurrent warfarin for therapeutic anticoagulation