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Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma

Contact Information

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Susan Swetter
(650) 852-3494
sswetter@stanford.edu

Recruiting Status: Recruiting

Stanford Recruiting Status: Recruiting

Investigator(s):

Description:

The overall objective of this randomized, double-blind, placebo-controlled Phase II trial is to determine the target tissue bioavailability and biomarker modulation effects of sulindac in individuals who have multiple atypical nevi.

Conditions Studied:

Lead Sponsor: NIH

Collaborator(s):

Intervention(s):

Phase: Phase 2


Eligibility

Key Inclusion Criteria:

4.1.1 >= 4 large (>=5 mm and <= 15 mm) atypical nevi (AN) and one benign nevus located on the body where biopsies are appropriate.

4.1.2 Healthy men and women age 18 to 65 years of age at their last birthday.

4.1.3 Karnofsky performance status of at least 80% (see Appendix A).

4.1.4 Normal organ and marrow function as defined below:
- Leukocytes (WBC) >=3,000/mL
- Absolute neutrophil count >=1,500/mL
- Platelets >=100,000/mL
- Bilirubin, total <= 2.0mg/dL
- AST (SGOT)/ALT (SGPT) <= 2.0 X institutional ULN
- Creatinine <= ULN (1.5 mg/dL)

4.1.5 Effective contraception (surgical sterilization, abstinence, hormonal contraception, barrier method, or at least one year post-menopausal).

4.1.6 Ability to understand and sign a written informed consent document and PHI Authorization Form.

Key Exclusion Criteria:

4.2.1 More than one prior cutaneous melanoma. Subjects may have had one prior stage I or IIa or IIb melanoma if they have been off treatment for >= three months.

4.2.2 Family history of >= 2 first degree relatives with melanoma.

4.2.3 Frequent, chronic or moderate/severe gastric complaints.

Upper gastrointestinal problems requiring prescription or nonprescription medical remedies for symptoms of heartburn, dyspepsia, nausea or abdominal pain more often than once per week on average. History of peptic ulcer, occult or gross intestinal bleeding. Any other similar events will be reviewed by a study physician for possible subject exclusion.

4.2.4 History of bleeding or clotting disorder; current or recent (within 3 months) use of coumadin or other systemic anticoagulant other than aspirin.

4.2.5 Current use of lithium, phenytoin or sulfonamides.

4.2.6 History of allergic reaction (e.g. urticaria, asthma, rhinitis) or gastric intolerance attributed to compounds of similar chemical or biologic composition to sulindac. Prior allergic reaction to aspirin will exclude UNLESS subsequent dosing with other NSAIDs has been well tolerated.

4.2.7 Have used NSAIDs for more than 5 days per month within 3 months of enrollment except low dose aspirin (81 mg QD).

4.2.8 Modified dermoscopy score of >= 4.8.

4.2.9 Histological diagnosis of melanoma on the baseline biopsy.

4.2.10 Invasive cancer or cancer treatment within the past five years, except non-melanoma skin cancer.

4.2.11 Immunosuppression by virtue of medication or disease. This includes AIDS patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy), as determined by the examining investigator/co-investigator.

4.2.12 Participants who are already enrolled or who plan to enroll in another clinical trial while enrolled in this study. If they have completed a clinical intervention trial recently, there must be a 30-day period between completing the previous study and entering this study.

4.2.13 History of allergic reaction to lidocaine or xylocaine.
4.2.14 Unwilling or unable to refrain from use of any non-study NSAID during the study period except low dose aspirin (81 mg QD).

4.2.15 Unwilling or unable to limit alcohol consumption to less than 3 servings per week during the study period.

4.2.16 Unwilling or unable to refrain from taking herbal medicines or above-standard vitamin or mineral during the study. A standard daily multivitamin/mineral supplement is acceptable; therapeutic doses (for instance calcium and Vitamin D for osteoporosis) may also be continued.

4.2.17 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Ages Eligible for Study: 18 years to 65 years

Genders Eligible for Study: Male and Female

Healthy Volunteers?: People with the conditions listed in this trial can not participate as controls.

Additional Study Details

Official Title: Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma

Anticipated start date: 12/10/2008

Study Type: Interventional

Purpose: Prevention

Allocation: Randomized

Masking: Double Blind

Control: none

Assignment: Parallel

Endpoints: Pharmacokinetics/dynamics

Primary Outcomes:

Secondary Outcomes:

Total Number to be Enrolled: 50

Total Number to be Enrolled at Stanford: 25


More Information

Trial Unique Id: SU-09252008-1310

Secondary ID(s)


Locations & Contacts
Stanford Locations & Contacts

Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA   94305

Primary contact:
Susan Swetter
(650) 852-3494
sswetter@stanford.edu

Non-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: 8/19/2009

PLEASE 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 email referral@medcenter.stanford.edu .

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