Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00755040

Purpose

RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.

PURPOSE: This randomized phase I trial is studying how well cyclosporine eye drops work in preventing graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.

Condition	Intervention	Phase
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms	Drug: cyclosporine ophthalmic emulsion Other: placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia primary myelofibrosis

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Eye Diseases Leukemia Lymphoma Multiple Myeloma Myelodysplastic Syndromes

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:

Efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease [ Time Frame: 1 year after transplant. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between Ocular Surface Disease Index and ophthalmologic examination [ Time Frame: 1 year after transplant ] [ Designated as safety issue: No ]

Estimated Enrollment:	256
Study Start Date:	October 2008
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.	Drug: cyclosporine ophthalmic emulsion Given as eye drops
Placebo Comparator: Arm II Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.	Other: placebo Given as eye drops

Detailed Description:

OBJECTIVES:

Primary

To assess the efficacy of cyclosporine ophthalmic emulsion (Restasis®) in the prevention of ocular graft-versus-host disease in patients who have undergone allogeneic stem cell transplantation for hematologic malignancies or bone marrow failure disorders.

Secondary

To correlate the Ocular Surface Disease Index with clinical ophthalmologic examination.

OUTLINE: This is a multicenter study. Patients are stratified according to age, type of transplant (related vs unrelated), and intensity of transplant (ablative vs other). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.
Arm II: Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.

Patients in both arms may also receive artificial tear drops at least twice daily as clinically necessary.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of hematologic malignancy or bone marrow failure disorder
Has undergone allogeneic stem cell transplantation within the past 80-120 days
No diagnosis of ocular graft-versus-host disease (GVHD)
No grade 4 acute GVHD
No relapse of underlying disease

PATIENT CHARACTERISTICS:

Life expectancy ≥ 6 months
No documented dry eye prior to undergoing stem cell transplantation
No history of documented ocular infections prior to or during stem cell transplantation
No significant non-GVHD ocular problem that would preclude study participation
No history of non-compliance

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755040

Locations

United States, California
Stanford University	Recruiting
Palo Alto, California, United States, 94305
Contact: Laura Johnston, M.D. 650-498-5568
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program 800-811-8480
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program 800-811-8480
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480
United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 989109
Contact: Mary Flowers, M.D. 206-667-5160

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Madan Jagasia, MD

Vanderbilt-Ingram Cancer 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

Responsible Party:	Madan Jagasia, M.D., Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00755040 History of Changes
Other Study ID Numbers:	VICC BMT0766, P30CA068485, VU-VICC-BMT-0766, VU-080786
Study First Received:	September 17, 2008
Last Updated:	April 19, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:

graft versus host disease
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma

stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:

Neoplasms
Graft vs Host Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Lymphoma, Large-Cell, Immunoblastic
Myelodysplastic-Myeloproliferative Diseases
Immune System Diseases
Neoplasms by Histologic Type

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Cyclosporins
Cyclosporine
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012