Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT00243087
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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BI 2536
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Julie M. Vose, MD
Role: STUDY_CHAIR
University of Nebraska
Locations
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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Other Identifiers
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BOEH-BI-1216.3
Identifier Type: -
Identifier Source: secondary_id
UNMC-16005
Identifier Type: -
Identifier Source: secondary_id
CDR0000446176
Identifier Type: -
Identifier Source: org_study_id