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| Descriptive Information Fields | |||||||||||||
| Brief Title † | CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma | ||||||||||||
| Official Title † | 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 † | Interventional | ||||||||||||
| Study Design † | Treatment, Open Label | ||||||||||||
| Primary Outcome Measure † | 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 ] | ||||||||||||
| Secondary Outcome Measure † | Time to progression [ Designated as safety issue: No ] Time to event analysis of response [ Designated as safety issue: No ] Toxicity as measured by NCI CTCAE v.3.0 [ Designated as safety issue: Yes ] |
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| Condition † | Lymphoma | ||||||||||||
| Intervention † | Drug: rituximab Drug: temsirolimus |
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| MEDLINE PMIDs | 15466208 | ||||||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||
| Enrollment † | 73 | ||||||||||||
| Start Date † | May 2005 | ||||||||||||
| Completion Date | |||||||||||||
| Eligibility Criteria † | 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 †† | |||||||||||||
| Location Countries † | United States | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00109967 | ||||||||||||
| Organization ID | CDR0000425334 | ||||||||||||
| Secondary IDs †† | NCCTG-N038H | ||||||||||||
| Study Sponsor † | North Central Cancer Treatment Group | ||||||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | June 2008 | ||||||||||||
| First Received Date † | May 3, 2005 | ||||||||||||
| Last Updated Date | June 11, 2008 | ||||||||||||