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