An Open Phase I Single Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma

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