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| Sponsors and Collaborators: |
North Central Cancer Treatment Group 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 |
| MedlinePlus related topics: | Cancer Lymphoma |
| ChemIDplus related topics: | CCI 779 |
| 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 |
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Study Chair: | Stephen M. Ansell, MD, PhD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Jun 9; [Epub ahead of print]
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Witzig TE, Ansell SM, Geyer SM, et al.: Anti-tumor activity of low-dose single agent CCI-779 for relapsed mantle cell lymphoma: a phase II trial in the North Central Cancer Treatment Group. [Abstract] J Clin Oncol 23 (Suppl 16): A-6504, 561s, 2005.
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Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 Aug 10;23(23):5347-56. Epub 2005 Jun 27.
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Witzig T, Geyer S, Ghobrial I, et al.: Anti-tumor activity of single-agent CCI-779 for relapsed mantle cell lymphoma: a phase II trial in the North Central Cancer Treatment Group. [Abstract] Blood 104 (11): A-129, 2004.
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Witzig TE, Geyer SM, Salim M, et al.: A phase II trial of the rapamycin analog CCI-779 in previously treated mantle cell non-Hodgkins lymphoma: interim analysis of 18 patients. [Abstract] Blood 102 (11 Pt 1): A-2374, 2003.
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| Study ID Numbers: | CDR0000069269, NCCTG-N0186 |
| First Received: | April 9, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033267 |
| Health Authority: | United States: Federal Government |
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