Non Hodgkin Lymphoma Clinical Trial

Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma

Summary

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.

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Full Description

OBJECTIVES:

Primary

Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.

Secondary

Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
Determine the toxicity of this drug in these patients.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
At least one objective measurable or evaluable disease parameter.
Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal.
Total bilirubin <= 2x the upper limit of normal.
Age 18 or older.

Exclusion Criteria:

Prior cyclosporine or Tacrolimus (FK506).
Prior allogeneic transplant.
Evidence of active infection.
Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
Evidence of active neurological impairment.
Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
pregnant or breastfeeding women.
Human immunodeficiency virus (HIV) positive.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT00070291

Recruitment Status:

Terminated

Sponsor:

Eastern Cooperative Oncology Group

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There are 19 Locations for this study

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Stanford Cancer Center
Stanford California, 94305, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60504, United States
Hematology Oncology Associates of Illinois - Berwyn
Berwyn Illinois, 60402, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Saint Joseph Hospital
Chicago Illinois, 60657, United States
Midwest Center for Hematology/Oncology
Joliet Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville Illinois, 60048, United States
La Grange Oncology Associates - Geneva
Naperville Illinois, 60563, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles Illinois, 60714, United States
Hematology Oncology Associates - Skokie
Skokie Illinois, 60076, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
St. Rita's Medical Center
Lima Ohio, 45801, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT00070291

Recruitment Status:

Terminated

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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