Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients Wit… (NCT00243087) | Clinical Trial Compass
CompletedPhase 1
Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)
United States41 participantsStarted 2005-07
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…
What they're measuring
1
Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
Timeframe: up to 22 days of each course
2
Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course