Status:
COMPLETED
Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
GlaxoSmithKline
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This will be a multi-center, Phase I, dose-escalation study of bortezomib in combination with 131I-tositumomab in patients with relapsed non-Hodgkin's lymphoma. Bortezomib will be administered to pati...
Eligibility Criteria
Inclusion
- Patients must have histologically proven relapsed or refractory MCL, DLBCL including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic large B cell lymphoma, or low grade B cell NHL.
- Patients must have received prior systemic therapy for their lymphoma.
- Age \>18 years.
- Life expectancy of greater than 12 weeks
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or boron.
- Previous radiation therapy to the maximum tissue tolerance at any site.
- Previous autologous or allogeneic stem cell transplantation.
- Involvement of the bone marrow of \>25% by lymphoma.
- Known involvement of the central nervous system by lymphoma. 17
- Significant organ dysfunction, including hematologic (absolute neutrophil count \<1500, platelets \<150,000).
- ECOG performance status \>2.
- Uncontrolled illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV infection.
- Patient has a calculated or measured creatinine clearance of \<20 mL/minute within 14 days before enrollment.
- Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 3 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00777114
Start Date
April 1 2007
End Date
December 18 2012
Last Update
August 13 2018
Active Locations (2)
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1
University of Michigan
Ann Arbor, Michigan, United States
2
Weill Cornell Medical College
New York, New York, United States, 10021