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

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	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

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

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 2017 (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
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

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

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

No publications provided

Responsible Party:	Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00070291 History of Changes
Other Study ID Numbers:	CDR0000331864, ECOG-2402
Study First Received:	October 3, 2003
Last Updated:	April 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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 February 12, 2012