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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00438802 |
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.
Condition | Intervention | Phase |
Lymphoma |
Drug: alefacept Procedure: flow cytometry Procedure: pharmacological study Procedure: polymorphism analysis |
Phase I |
MedlinePlus related topics: | Cancer Lymphoma |
ChemIDplus related topics: | Alefacept Salicylsalicylic acid Sodium salicylate |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-Cell Lymphoma and Peripheral T-Cell NHL |
Estimated Enrollment: | 24 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma (CTCL) or peripheral T-cell non-Hodgkin's lymphoma
Relapsed or refractory disease
Patients with CTCL must have failed ≥ 2 skin-directed therapies
Measurable disease, defined as at least 1 bidimensionally measurable lesion > 2 cm by CT scan, MRI, physical exam, or photograph with appended ruler
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |||||
City of Hope Comprehensive Cancer Center | |||||
Duarte, California, United States, 91010-3000 | |||||
United States, Iowa | |||||
Holden Comprehensive Cancer Center at University of Iowa | |||||
Iowa City, Iowa, United States, 52242-1002 | |||||
United States, Maryland | |||||
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
Baltimore, Maryland, United States, 21231-2410 | |||||
United States, Minnesota | |||||
Mayo Clinic Cancer Center | |||||
Rochester, Minnesota, United States, 55905 |
Mayo Clinic |
National Cancer Institute (NCI) |
Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
Investigator: | Mark R. Pittelkow, MD | Mayo Clinic |
Investigator: | Brian Link, MD | Holden Comprehensive Cancer Center |
Investigator: | Yvette L. Kasamon, MD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Jasmine M. Zain, MD | Beckman Research Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000530071, MAYO-LS058C, MAYO-06-002246 |
First Received: | February 20, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00438802 |
Health Authority: | United States: Federal Government |
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