An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
- NCT00243087
- PHASE1
- INTERVENTIONAL
Last updated: 2013-11-01
Purpose of Trial
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.
This study is for people with
Lymphoma
Interventions being studied
BI 2536
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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
4 Locations
Washington
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
District of Columbia, 20007, United States
Omaha
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Nebraska, 68198-6805, United States
Rochester
James P. Wilmot Cancer Center at University of Rochester Medical Center
New York, 14642, United States
Houston
M. D. Anderson Cancer Center at University of Texas
Texas, 77030-4009, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov
