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

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00070291
First received: October 3, 2003
Last updated: February 12, 2013
Last verified: February 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Response Rate (Complete and Partial Response) [ Time Frame: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up. ] [ Designated as safety issue: No ]
    Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year. ] [ Designated as safety issue: No ]
    Overall survival was defined as time from randomization to death from any cause.


Enrollment: 4
Study Start Date: September 2005
Study Completion Date: May 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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 Names:
  • CSA,
  • Neoral,
  • Gengraf

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

Inclusion Criteria:

  • Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
  • 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 cyclosporine or Tacrolimus (FK506).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
Hematology Oncology Associates of Illinois - Berwyn
Berwyn, Illinois, United States, 60402
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Saint Joseph Hospital
Chicago, Illinois, United States, 60657
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
La Grange Oncology Associates - Geneva
Naperville, Illinois, United States, 60563
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States, 60714
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Ohio
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Ranjana Advani, MD Stanford University
  More Information

No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00070291     History of Changes
Other Study ID Numbers: CDR0000331864, U10CA021115, E2402
Study First Received: October 3, 2003
Results First Received: January 7, 2013
Last Updated: February 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
angioimmunoblastic T-cell lymphoma

Additional relevant MeSH terms:
Immunoblastic Lymphadenopathy
Lymphoma
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoma, Non-Hodgkin
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014