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

Inclusion Criteria

• •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