Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
NCT ID: NCT00070291
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2006-01-24
2011-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
cyclosporine
Cyclosporine doses will be based on actual body weight unless actual body weight is \> 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
Interventions
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cyclosporine
Cyclosporine doses will be based on actual body weight unless actual body weight is \> 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Ranjana Advani, MD
Role: STUDY_CHAIR
Stanford University
Locations
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Stanford Cancer Center
Stanford, California, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Hematology and Oncology Associates
Chicago, Illinois, United States
Saint Joseph Hospital
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
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
St. Rita's Medical Center
Lima, Ohio, United States
Countries
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Other Identifiers
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E2402
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000331864
Identifier Type: -
Identifier Source: org_study_id
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