Sirolimus as Secondary Therapy in Treating Patients With Chronic Graft-Versus-Host Disease That Did Not Respond to Previous Systemic Treatment - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00079183

Purpose

RATIONALE: Sirolimus may be effective in treating chronic graft-versus-host disease that has not responded to previous systemic treatment.

PURPOSE: This phase II trial is studying how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease that has not responded to previous systemic treatment.

Condition	Intervention	Phase
Graft Versus Host Disease	Drug: cyclosporine Drug: prednisone Drug: sirolimus Drug: tacrolimus	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Supportive Care
Official Title:	A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Sirolimus for Secondary Treatment of Chronic Graft-Versus-Host Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Prednisone Sirolimus Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Benefit

Secondary Outcome Measures:

Safety

Study Start Date:	April 2002
Study Completion Date:	June 2010

Detailed Description:

OBJECTIVES:

Determine the safety of sirolimus as secondary treatment for patients with chronic graft-versus-host disease who had an inadequate response to prior systemic treatment.
Determine the efficacy of this drug in these patients.

OUTLINE: This is an open-label study.

Patients continue on oral prednisone and oral cyclosporine OR tacrolimus. Patients also receive oral sirolimus once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 3 years.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed chronic graft-versus-host disease (GVHD)
- Inadequate response to prior treatment
- Requires secondary systemic therapy as a result of 1 of the following:
  - Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ
  - Development of signs or symptoms of chronic GVHD in a previously uninvolved organ
  - No improvement after 3 months of primary treatment
  - Continued need for at least 1.0 mg/kg/day of prednisone for more than 2 months without qualifying for type of donor, graft, or conditioning regimen
No persistent or recurrent malignancy, including histologically confirmed myeloma or lymphoma
- Patients with bcr/abl detected by polymerase chain reaction assay as the only evidence of persistent chronic myeloid leukemia allowed

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 50,000/mm^3

Hepatic

Not specified

Renal

Not specified

Immunologic

No fungal or viral infection without radiographic evidence of improvement during continued appropriate antimicrobial therapy
No cytomegalovirus antigenemia unresponsive to antiviral therapy
No active disseminated varicella-zoster viral infection with persistent non-crusted lesions

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to tolerate oral medicine
No prior hypersensitivity to sirolimus

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

See Disease Characteristics
Concurrent prednisone allowed

Radiotherapy

Not specified

Surgery

Not specified

Other

No concurrent systemic immunosuppressive medications except cyclosporine or tacrolimus
No concurrent grapefruit juice
No concurrent ketoconazole or voriconazole
No concurrent topical immunosuppressive treatment for chronic GVHD allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079183

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Paul Carpenter, MD

Fred Hutchinson Cancer Research Center

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

ClinicalTrials.gov Identifier:	NCT00079183 History of Changes
Other Study ID Numbers:	1706.00, FHCRC-1706.00, CDR0000355110
Study First Received:	March 8, 2004
Last Updated:	October 1, 2010
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:

graft versus host disease

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Tacrolimus
Prednisone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012