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| Descriptive Information Fields | |||||||||||||||||||||
| Brief Title † | Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma | ||||||||||||||||||||
| Official Title † | A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-Cell Lymphoma and Peripheral T-Cell NHL | ||||||||||||||||||||
| Brief Summary | RATIONALE: Combinations of biological substances in alefacept may be able to carry cancer-killing substances directly to cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study.
Cohorts of 6 patients receive escalating doses of alefacept until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal immunologic dose is defined as the dose that does not exceed the MTD, has the highest alefacept level, and achieves saturation of CD2 receptors.
Patients who experience disease progression during maintenance therapy may receive reinduction therapy* comprising 4 weekly doses of alefacept. The patient then proceeds to a second maintenance phase in the absence of disease progression. NOTE: *Only 1 reinduction allowed. Patients undergo blood and tissue collection periodically for pharmacological studies. Blood serum is analyzed for alefacept concentration, cytokine concentration, CD16 polymorphisms, and CD2 saturation via flow cytometry. After completion of study treatment, patients are followed every 3 months for up to 3 years and then periodically thereafter. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study. |
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| Study Phase | Phase I | ||||||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||||||
| Study Design † | Treatment | ||||||||||||||||||||
| Primary Outcome Measure † | Tolerability [ Designated as safety issue: Yes ] Immunostimulation [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Clinical response [ Designated as safety issue: No ] | ||||||||||||||||||||
| Condition † | Lymphoma | ||||||||||||||||||||
| Intervention † | Drug: alefacept Procedure: flow cytometry Procedure: pharmacological study Procedure: polymorphism analysis |
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| MEDLINE PMIDs | |||||||||||||||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||||||||||
| Enrollment † | 24 | ||||||||||||||||||||
| Start Date † | March 2006 | ||||||||||||||||||||
| Completion Date | |||||||||||||||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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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 † | NCT00438802 | ||||||||||||||||||||
| Organization ID | CDR0000530071 | ||||||||||||||||||||
| Secondary IDs †† | MAYO-LS058C, MAYO-06-002246 | ||||||||||||||||||||
| Study Sponsor † | Mayo Clinic | ||||||||||||||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||||||||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||
| Verification Date | March 2008 | ||||||||||||||||||||
| First Received Date † | February 20, 2007 | ||||||||||||||||||||
| Last Updated Date | October 29, 2008 | ||||||||||||||||||||