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

October 3, 2003
February 12, 2013
September 2005
March 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00070291 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
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Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
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
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.
Intervention: Drug: cyclosporine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
May 2011
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00070291
CDR0000331864, U10CA021115, E2402
No
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Ranjana Advani, MD Stanford University
Eastern Cooperative Oncology Group
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP