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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070291 |
Purpose
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
| Condition | Intervention | Phase |
|
Lymphoma |
Drug: cyclosporine |
Phase II |
| MedlinePlus related topics: | Cancer Lymphoma |
| Drug Information available for: | Cyclosporine Cyclosporin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma |
| Estimated Enrollment: | 27 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed angioimmunoblastic T-cell lymphoma
At least 1 measurable or evaluable disease parameter
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin no greater than 2 times ULN
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |||||
| Carle Cancer Center at Carle Foundation Hospital | Recruiting | ||||
| Urbana, Illinois, United States, 61801 | |||||
| Contact: Clinical Trials Office - Carle Cancer Center 800-446-5532 | |||||
| CCOP - Carle Cancer Center | Recruiting | ||||
| Urbana, Illinois, United States, 61801 | |||||
| Contact: Clinical Trials Office - CCOP - Carle Cancer Center 800-446-5532 | |||||
| Joliet Oncology-Hematology Associates, Limited - West | Recruiting | ||||
| Joliet, Illinois, United States, 60435 | |||||
| Contact: Kendrith M. Rowland, MD 217-383-3019 | |||||
| Rush-Copley Cancer Care Center | Recruiting | ||||
| Aurora, Illinois, United States, 60504 | |||||
| Contact: Kendrith M. Rowland, MD 217-383-3019 | |||||
| United States, Indiana | |||||
| Saint Anthony Memorial Health Centers | Recruiting | ||||
| Michigan City, Indiana, United States, 46360 | |||||
| Contact: Kendrith M. Rowland, MD 217-383-3019 | |||||
| United States, Iowa | |||||
| Mercy Medical Center - Sioux City | Recruiting | ||||
| Sioux City, Iowa, United States, 51104 | |||||
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |||||
| Siouxland Hematology-Oncology Associates, LLP | Recruiting | ||||
| Sioux City, Iowa, United States, 51101 | |||||
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |||||
| St. Luke's Regional Medical Center | Recruiting | ||||
| Sioux City, Iowa, United States, 51104 | |||||
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |||||
| United States, Maryland | |||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | ||||
| Baltimore, Maryland, United States, 21231-2410 | |||||
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |||||
| United States, Michigan | |||||
| Borgess Medical Center | Recruiting | ||||
| Kalamazoo, Michigan, United States, 49001 | |||||
| Contact: Raymond S. Lord, MD 269-373-7458 | |||||
| Bronson Methodist Hospital | Recruiting | ||||
| Kalamazoo, Michigan, United States, 49007 | |||||
| Contact: Raymond S. Lord, MD 269-373-7458 | |||||
| West Michigan Cancer Center | Recruiting | ||||
| Kalamazoo, Michigan, United States, 49007-3731 | |||||
| Contact: Clinical Trials Office - West Michigan Cancer Center 269-373-7458 | |||||
| United States, Ohio | |||||
| Case Comprehensive Cancer Center | Recruiting | ||||
| Cleveland, Ohio, United States, 44106-5065 | |||||
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |||||
| St. Rita's Medical Center | Recruiting | ||||
| Lima, Ohio, United States, 45801 | |||||
| Contact: Clinical Trials Office - St. Rita's Medical Center 419-226-9617 | |||||
| Eastern Cooperative Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Ranjana Advani, MD | Stanford University |
| Investigator: | Sandra J. Horning, MD | Stanford University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000331864, ECOG-2402 |
| First Received: | October 3, 2003 |
| Last Updated: | November 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00070291 |
| Health Authority: | Unspecified |
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