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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033267 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: temsirolimus |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma |
| Study Start Date: | April 2002 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Unidimensionally measurable lymph node or lesion
One of the following measurement parameters may be used:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 166 Study Locations| Study Chair: | Stephen M. Ansell, MD, PhD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000069269, NCCTG-N0186 |
| Study First Received: | April 9, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033267 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent mantle cell lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |