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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00377052 |
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. 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 help gemcitabine work better by making cancer cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: bortezomib Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma |
| Enrollment: | 29 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter until relapse/progression.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma
Not refractory to prior therapy
Clinically and/or radiologically documented disease
At least 1 site of disease must be bidimensionally measurable by CT scan or MRI with ≥ 1 lesion meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No other serious illness or medical condition that would preclude compliance with study requirements, including any of the following:
Uncontrolled or severe cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior radiotherapy and recovered
Contacts and Locations| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| BCCA - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| QEII, CCR, Hematology Research | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Juravinski Cancer Centre at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 4L6 | |
| Odette Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Univ. Health Network-Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| McGill University - Dept. Oncology | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Principal Investigator: | C. Tom Kouroukis, MD | Margaret and Charles Juravinski Cancer Centre |
More Information
| Responsible Party: | Ralph Meyer, M.D., NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00377052 History of Changes |
| Other Study ID Numbers: | I172, CAN-NCIC-IND172, ORTHO-CAN-NCIC-IND172, CDR0000493021 |
| Study First Received: | September 13, 2006 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Canada: Health Canada |
|
recurrent mantle cell lymphoma |
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Gemcitabine Bortezomib Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Protease Inhibitors |