Christopher Ta, MD
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
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: cyclosporine ophthalmic emulsion
- Drug: placebo
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion 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
Key Exclusion Criteria:
Additional Study Details
Official Title:
Randomized Placebo Controlled Double Blind Study of Restasis Versus Placebo in Primary Prevention of Ocular GVHD After Allogeneic Stem Cell TransplantationAnticipated start date:
5/21/2009Lead Sponsor:
Vanderbilt UniversityCollaborator(s):
- NCI
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Efficacy of cyclosporine ophthalmic emulsion (Restasis?) in the prevention of ocular graft-versus-host disease [ Designated as safety issue: No ]
Secondary Outcomes:
- Correlation between Ocular Surface Disease Index and ophthalmologic examination [ Designated as safety issue: No ]
Total Number to be Enrolled:
256Total Number to be Enrolled at Stanford:
40More Information
Secondary ID(s):
- BMT205
- CDR0000614434
- NCT00755040
- VU-080786
- VU-VICC-BMT-0766
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/2/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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