Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage IV adult diffuse large cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, stage IV grade 3 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult T-cell leukemia/lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma
Eligibility 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
Sites / Locations
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- M. D. Anderson Cancer Center at University of Texas