Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
- Registration Number
- NCT00070291
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cyclosporine cyclosporine High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
- Primary Outcome Measures
Name Time Method Response Rate (Complete and Partial Response) Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up. Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of \> 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.
- Secondary Outcome Measures
Name Time Method Overall Survival Assessed every 3 months for 2 years, then every 6 months for 1 year. Overall survival was defined as time from randomization to death from any cause.
Trial Locations
- Locations (23)
Hematology Oncology Associates of Illinois - Berwyn
🇺🇸Berwyn, Illinois, United States
Hematology Oncology Associates - Skokie
🇺🇸Skokie, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Saint Joseph Hospital
🇺🇸Chicago, Illinois, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Hematology and Oncology Associates
🇺🇸Chicago, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
🇺🇸Libertyville, Illinois, United States
La Grange Oncology Associates - Geneva
🇺🇸Naperville, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles
🇺🇸Niles, Illinois, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States