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

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ClinicalTrials.gov Identifier: NCT00070291
Recruitment Status : Terminated (Slow accrual.)
First Posted : October 7, 2003
Results First Posted : February 8, 2013
Last Update Posted : February 15, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Lymphoma Drug: cyclosporine Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
Study Start Date : September 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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 :
  1. Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year. ]
    Overall survival was defined as time from randomization to death from any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070291


Locations
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Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Ranjana Advani, MD Stanford University
More Information
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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00070291    
Other Study ID Numbers: CDR0000331864
U10CA021115 ( U.S. NIH Grant/Contract )
E2402 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Posted: October 7, 2003    Key Record Dates
Results First Posted: February 8, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Eastern Cooperative Oncology Group:
angioimmunoblastic T-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphadenopathy
Cyclosporine
 Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors