RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.

PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have recurrent or refractory angioimmunoblastic T-cell lymphoma.

Condition	Treatment or Intervention	Phase
angioimmunoblastic T-cell lymphoma	Drug: cyclosporine  Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy	Phase II

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 36 weeks in the absence of disease progression or unacceptable toxicity.

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed angioimmunoblastic T-cell lymphoma
• Recurrent or refractory disease
• At least 1 measurable or evaluable disease parameter
• Biopsy-proven skin disease alone may constitute evaluable disease
• Constitutional symptoms and evidence of hemolysis alone do not constitute evaluable disease
• Failed at least 1 type of prior treatment (i.e., chemotherapy, autologous transplantation, or steroid treatment)

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No liver failure
• Alkaline phosphatase no greater than 2 times upper limit of normal (ULN)
• AST and ALT no greater than 2 times ULN
• Bilirubin no greater than 2 times ULN
• If total bilirubin is elevated, bilirubin should be fractionated and direct bilirubin must be normal

Renal

• No kidney failure
• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No congestive heart failure

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No history of hypersensitivity to cyclosporine and/or Cremophor EL (polyoxyethylated oil)
• No history of other malignancy except cured carcinoma in situ of the cervix or basal cell skin cancer
• No evidence of active infection
• No evidence of active neurological impairment
• No other severe comorbidity

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• No prior allogeneic transplantation

Chemotherapy

• See Disease Characteristics
• No concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• Concurrent steroids allowed, but taper must be planned with goal of no steroids by week 3 of study treatment

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior cyclosporine
• No prior tacrolimus
• No concurrent allopurinol

Study chairs or principal investigators

Ranjana Advani, MD,  Study Chair,  Stanford University   
Sandra J. Horning, MD,  Stanford University   

Study ID Numbers:  CDR0000331864; ECOG-2402
Record last reviewed:  September 2003
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070291
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20