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

NCT00243087 | Completed Phase 1

• 3 other identifiers: CDR0000446176BOEH-BI-1216.3UNMC-16005
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course

  up to 22 days of each course

• Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course

  up to 22 days of each course

Secondary Outcomes (2)

• Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course

  day 22 of every second course

• Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course

  day 22 of each course

Interventions

BI 2536 DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, Large-Cell, Immunoblastic; Lymphoma, Large-Cell, Anaplastic; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

BI 2536

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, T-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• Julie M. Vose, MD

  University of Nebraska

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: July 1, 2005
• Primary Completion: August 1, 2008
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (4)