search
Back to results

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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BI 2536
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • M. D. Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00243087
Brief Title
Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)
Official Title
An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.
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 this drug in these patients. Secondary Determine the pharmacokinetic profile of this drug in these patients. Determine, preliminarily, the antitumor activity of this drug in these patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BI 2536
Primary Outcome Measure Information:
Title
Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
Time Frame
up to 22 days of each course
Title
Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course
Time Frame
up to 22 days of each course
Secondary Outcome Measure Information:
Title
Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course
Time Frame
day 22 of every second course
Title
Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course
Time Frame
day 22 of each course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M. Vose, MD
Organizational Affiliation
University of Nebraska
Official's Role
Study Chair
Facility Information:
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs