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| Sponsor: | Robert H. Lurie Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00290706 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with gemcitabine and to see how well they work in treating patients with relapsed or refractory B-cell or T-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: bortezomib Drug: gemcitabine hydrochloride |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I/II Trial of Combination Bortezomib (VELCADE®) and Gemcitabine Therapy for Patients With Relapsed or Refractory Aggressive B- and T-Cell Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 37 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of bortezomib followed by a phase II, open-label study.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity (DLT) OR the dose that at which 2 of 6 patients experience DLT.
After completion of study therapy, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B- or T-cell non-Hodgkin's lymphoma (NHL)
Intermediate histology B-cell NHL, including any of the following:
Must have received 1-3 prior therapeutic regimens
PATIENT CHARACTERISTICS:
Platelet count ≥ 100,000/mm^3
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Sonali M. Smith, MD 773-834-2895 smsmith@medicine.bsd.uchicago.edu | |
| Veterans Affairs Medical Center - Lakeside Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Andrew M. Evens, DO, MS 312-695-4537 a-evens@northwestern.edu | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| United States, New York | |
| SUNY Downstate Medical Center | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Olcay Batuman, MD 718-270-2785 obatuman@downstate.edu | |
| Principal Investigator: | Andrew M. Evens, DO, MS | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Andrew M. Evens ) |
| Study ID Numbers: | CDR0000456477, NU-04H4, NU-1346-011, NU-200411-0379, MILLENNIUM-NU-04H4, LILLY-NU-04H4, VEL-03-082 |
| Study First Received: | February 9, 2006 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00290706 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
recurrent grade 3 follicular lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Lymphoma, T-Cell Therapeutic Uses Gemcitabine Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Bortezomib Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Radiation-Sensitizing Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |