Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00243087 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: BI 2536 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled |
Official Title: | An Open Phase I Single Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 50 |
Study Start Date: | July 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, open-label, uncontrolled, multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BI 2536 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity during the first treatment course. Up to 24 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically until disease progression or initiation of another cancer treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
T-cell NHL, including any of the following subtypes:
Refractory (i.e., disease not amenable to standard therapy) or relapsed disease, as evidenced by 1 of the following:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
More than 3 weeks since prior and no concurrent radiotherapy
Other
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198-6805 | |
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 | |
United States, New York | |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Jonathan W. Friedberg, MD 585-273-4150 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Study Chair: | Julie M. Vose, MD | University of Nebraska |
Study ID Numbers: | CDR0000446176, BOEH-BI-1216.3, UNMC-16005 |
Study First Received: | October 20, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00243087 History of Changes |
Health Authority: | Unspecified |
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 |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Mantle-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma, Follicular Mantle Cell Lymphoma Follicular Lymphoma Recurrence Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Burkitt's Lymphoma |
Lymphatic Diseases Leukemia Burkitt Lymphoma Lymphoma, Large-Cell, Immunoblastic Leukemia, T-Cell Lymphoma, Large-Cell, Anaplastic Anaplastic Large Cell Lymphoma Lymphoma, Large-cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |