Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Ranjana Advani

Study Chair

Sandra J. Horning

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00070291
Information obtained from ClinicalTrials.gov on December 14, 2011

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