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



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

For Condition: angioimmunoblastic T-cell lymphoma
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SandraHorning,  ,  Stanford University


Additional Information:
Study ID Numbers:  CDR0000331864;  ECOG-2402
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070291

Other Angioimmunoblastic T-Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma

2. Salvage Chemotherapy Using Dexamethasone and Cisplatin Combined With Either Gemcitabine or Cytarabine Before Autologous Stem Cell Transplantation With or Without Maintenance Rituximab in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

3. Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin’s Lymphoma

4. Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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

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