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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | May 3, 2005 | ||||||||||||
| Last Updated Date | April 14, 2009 | ||||||||||||
| Start Date ICMJE | May 2005 | ||||||||||||
| Estimated Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Response rate (complete, partial, and unconfirmed) during the first 24 weeks of treatment as defined by the International Workshop criteria [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Response rate (complete, partial, and unconfirmed) during the first 24 weeks of treatment as defined by the International Workshop criteria | ||||||||||||
| Change History | Complete list of historical versions of study NCT00109967 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||
| Brief Title ICMJE | CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma | ||||||||||||
| Official Title ICMJE | A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma | ||||||||||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are stratified according to prior response to rituximab (sensitive [partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last treatment with rituximab alone or in combination with chemotherapy] vs refractory [stable or progressive disease OR a PR or CR that lasted < 6 months after the last treatment with rituximab alone or in combination with chemotherapy]). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment. After completion of study treatment, 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 total of 40-73 patients (24-45 in stratum 1 and 16-28 in stratum 2) will be accrued for this study within approximately 3 years. |
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| Study Phase | Phase II | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Open Label | ||||||||||||
| Condition ICMJE | Lymphoma | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||
| Publications * | Jazirehi AR, Vega MI, Chatterjee D, Goodglick L, Bonavida B. Inhibition of the Raf-MEK1/2-ERK1/2 signaling pathway, Bcl-xL down-regulation, and chemosensitization of non-Hodgkin's lymphoma B cells by Rituximab. Cancer Res. 2004 Oct 1;64(19):7117-26. | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 73 | ||||||||||||
| Completion Date | |||||||||||||
| Estimated Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00109967 | ||||||||||||
| Responsible Party | Jan C. Buckner, North Central Cancer Treatment Group | ||||||||||||
| Study ID Numbers ICMJE | CDR0000425334, NCCTG-N038H | ||||||||||||
| Study Sponsor ICMJE | North Central Cancer Treatment Group | ||||||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | March 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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