Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Lymphoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

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 tre...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of BI 2536 in patients with refractory or relapsed advanced aggressive non-Hodgkin's lymphoma. * Determine the safety and tolerability of t...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    41 Patients enrolled

    Trial Details

    Trial ID

    NCT00243087

    Start Date

    July 1 2005

    Last Update

    December 20 2024

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

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

    2

    UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, United States, 68198-6805

    3

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

    Rochester, New York, United States, 14642

    4

    M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009