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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

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