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

Tracking Information

First Received Date ^ICMJE

October 3, 2003

Last Updated Date

April 14, 2009

Start Date ^ICMJE

September 2005

Estimated Primary Completion Date

November 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Response rate (complete and partial response)

Change History

Complete list of historical versions of study NCT00070291 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Toxicity
Disease-free survival
Progression-free survival
Overall survival

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Drug: cyclosporine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

November 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00070291

Responsible Party

Robert L. Comis, ECOG Group Chair's Office

Study ID Numbers ^ICMJE

CDR0000331864, ECOG-2402

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2009

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