Clinical trial NCT00070291: Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Official title: A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
Keywords: angioimmunoblastic T-cell lymphoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-10-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Response Rate (Complete and Partial Response)
timeFrame: 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.
Secondary outcomes:
measure: Overall Survival
timeFrame: Assessed every 3 months for 2 years, then every 6 months for 1 year.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Aurora
country: United States
facility: Rush-Copley Cancer Care Center
state: Illinois
city: Berwyn
country: United States
facility: Hematology Oncology Associates of Illinois - Berwyn
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Hematology and Oncology Associates
state: Illinois
city: Chicago
country: United States
facility: Saint Joseph Hospital
state: Illinois
city: Joliet
country: United States
facility: Midwest Center for Hematology/Oncology
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Limited - West
state: Illinois
city: Libertyville
country: United States
facility: North Shore Oncology and Hematology Associates, Limited - Libertyville
state: Illinois
city: Naperville
country: United States
facility: La Grange Oncology Associates - Geneva
state: Illinois
city: Niles
country: United States
facility: Cancer Care and Hematology Specialists of Chicagoland - Niles
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Associates - Skokie
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center at Carle Foundation Hospital
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Michigan City
country: United States
facility: Saint Anthony Memorial Health Centers
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Sioux City
country: United States
facility: Mercy Medical Center - Sioux City
state: Iowa
city: Sioux City
country: United States
facility: St. Luke's Regional Medical Center
state: Iowa
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Lima
country: United States
facility: St. Rita's Medical Center
state: Ohio
Study officials:
affiliation: Stanford University
name: Ranjana Advani, MD
role: STUDY_CHAIR
References: