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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2008

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070291
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: cyclosporine
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Cyclosporine    Cyclosporin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:   27
Study Start Date:   September 2005
Estimated Primary Completion Date:   November 2007 (Final data collection date for primary outcome measure)

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070291

Locations
United States, California
Stanford Cancer Center     Recruiting
      Stanford, California, United States, 94305-5824
      Contact: Clinical Trials Office - Stanford Cancer Center     650-498-7061     cctoffice@stanford.edu    
United States, Illinois
Cancer Care and Hematology Specialists of Chicagoland - Niles     Recruiting
      Niles, Illinois, United States, 60714
      Contact: Leo I. Gordon, MD     847-827-9060        
Carle Cancer Center at Carle Foundation Hospital     Recruiting
      Urbana, Illinois, United States, 61801
      Contact: Clinical Trials Office - Carle Cancer Center     800-446-5532        
CCOP - Carle Cancer Center     Recruiting
      Urbana, Illinois, United States, 61801
      Contact: Clinical Trials Office - CCOP - Carle Cancer Center     800-446-5532        
Hematology and Oncology Associates     Recruiting
      Chicago, Illinois, United States, 60611
      Contact: Clinical Trails Office - Hematology and Oncology Associates     312-695-1301        
Rush-Copley Cancer Care Center     Recruiting
      Aurora, Illinois, United States, 60504
      Contact: Kendrith M. Rowland, MD     217-383-3010        
Joliet Oncology-Hematology Associates, Limited - West     Recruiting
      Joliet, Illinois, United States, 60435
      Contact: Kendrith M. Rowland, MD     217-383-3010        
Midwest Center for Hematology/Oncology     Recruiting
      Joliet, Illinois, United States, 60432
      Contact: Leo I. Gordon, MD     815-740-1400        
North Shore Oncology and Hematology Associates, Limited - Libertyville     Recruiting
      Libertyville, Illinois, United States, 60048
      Contact: Leo I. Gordon, MD     847-367-6781        
Robert H. Lurie Comprehensive Cancer Center at Northwestern University     Recruiting
      Chicago, Illinois, United States, 60611-3013
      Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
Hematology Oncology Associates - Skokie     Recruiting
      Skokie, Illinois, United States, 60076
      Contact: Leo I. Gordon, MD     847-568-9930        
Veterans Affairs Medical Center - Chicago Westside Hospital     Recruiting
      Chicago, Illinois, United States, 60612
      Contact: Leo I. Gordon, MD     312-569-6129        
United States, Indiana
Saint Anthony Memorial Health Centers     Recruiting
      Michigan City, Indiana, United States, 46360
      Contact: Kendrith M. Rowland, MD     217-383-3010        
United States, Iowa
Mercy Medical Center - Sioux City     Recruiting
      Sioux City, Iowa, United States, 51104
      Contact: Donald B. Wender, MD, PhD     712-252-9326        
Siouxland Hematology-Oncology Associates, LLP     Recruiting
      Sioux City, Iowa, United States, 51101
      Contact: Donald B. Wender, MD, PhD     712-252-9326        
St. Luke's Regional Medical Center     Recruiting
      Sioux City, Iowa, United States, 51104
      Contact: Donald B. Wender, MD, PhD     712-252-9326        
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins     Recruiting
      Baltimore, Maryland, United States, 21231-2410
      Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
United States, Michigan
Borgess Medical Center     Recruiting
      Kalamazoo, Michigan, United States, 49001
      Contact: Raymond S. Lord, MD     269-373-7488        
Bronson Methodist Hospital     Recruiting
      Kalamazoo, Michigan, United States, 49007
      Contact: Raymond S. Lord, MD     269-373-7488        
West Michigan Cancer Center     Recruiting
      Kalamazoo, Michigan, United States, 49007-3731
      Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
United States, Ohio
Case Comprehensive Cancer Center     Recruiting
      Cleveland, Ohio, United States, 44106-5065
      Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
St. Rita's Medical Center     Recruiting
      Lima, Ohio, United States, 45801
      Contact: Clinical Trials Office - St. Rita's Medical Center     419-226-9617        

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Ranjana Advani, MD     Stanford University    
Investigator:     Sandra J. Horning, MD     Stanford University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000331864, ECOG-2402
First Received:   October 3, 2003
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00070291
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
angioimmunoblastic T-cell lymphoma  

Study placed in the following topic categories:
Lymphatic Diseases
Cyclosporine
Immunoproliferative Disorders
Clotrimazole
Miconazole
Lymphoma, T-Cell
Tioconazole
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Cyclosporins
Lymphoma
Recurrence

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 07, 2008




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