Know Cancer

forgot password

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

Phase 2
18 Years
65 Years
Open (Enrolling)
Precancerous Condition

Thank you

Trial Information

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


I. Determine sulindac and sulindac metabolites (sulindac sulfone and sulindac sulfide)
levels in healthy participants with atypical nevi (abnormal moles) and benign nevus at
increased risk for melanoma treated with sulindac versus placebo.


I. Assess the effects of sulindac on apoptosis in atypical nevi of these participants.

II. Assess the effects of sulindac on vascular endothelial growth factor (VEGF) expression
in atypical nevi of these participants.

III. Assess sulindac and metabolite levels in plasma and its association with drug levels in
the target tissue.

OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.

- Sulindac arm: Participants receive oral sulindac 150 mg twice daily.

- Placebo arm: Participants receive oral placebo twice daily.

In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.

Blood and tissue samples are collected at baseline and/or after completion of study therapy
and analyzed for sulindac and metabolite levels via high performance liquid chromatography
tandem mass spectrometry; the expression of the marker of apoptosis, cleaved caspase 3, and
VEGF in atypical nevi was determined via immunohistochemistry assays.

After completion of study therapy, participants are followed for 2 weeks.

Inclusion Criteria


- Healthy participants at risk for developing melanoma and meeting the following

- Must have ≥ 4 large (≥ 5 mm and < 15 mm) atypical nevi

- Must have 1 benign nevus amenable to biopsies

- No histologically confirmed melanoma on the baseline biopsy

- No more than 1 prior cutaneous melanoma

- One prior stage I, IIA, or IIB melanoma allowed provided patients have been off
treatment > 3 months

- No family history of melanoma involving ≥ 2 first degree relatives

- Modified dermoscopy score < 4.8


- Karnofsky performance status 80-100%

- White blood cell count(WBC) ≥ 3,000/mm³

- Absolute neutrophil count (ANC) ≥ 1,500/mm³

- Platelets count ≥ 100,000/mm³

- Total bilirubin ≤ 2.0 mg/dL

- Aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤ 2.0 times upper limit
of normal

- Creatinine ≤ 1.5 mg/dL

- Not pregnant or nursing

- Fertile patients must use effective contraception

- More than 6 months since prior and no concurrent tanning bed use or other methods to
promote sun-tanning

- Willing to minimize sunlight exposure by applying sunscreen/sunblock or wearing
clothing to shield skin during outdoor activity during study participation

- Willing or able to limit alcohol consumption to less than 3 servings a week during
the study period

- No frequent, chronic or moderate/severe gastrointestinal (GI) complaints including,
but not limited to, any of the following:

- Upper GI problems requiring prescription or nonprescription medical remedies for
symptoms of heartburn, dyspepsia, nausea, or abdominal pain > once a week on

- History of peptic ulcer, occult or gross intestinal bleeding

- No prior allergic reaction to aspirin (unless subsequent dosing with other NSAIDs has
been well tolerated)

- No history of allergic reaction to lidocaine or xylocaine

- No history of allergic reaction (e.g., urticaria, asthma, or rhinitis) or gastric
intolerance attributed to compounds of similar chemical or biological composition to

- No history of bleeding or clotting disorder

- No invasive cancer or cancer treatment within the past 5 years, except nonmelanoma
skin cancer

- No immunosuppression by medication or disease, including any of the following:


- Oral prednisone

- Immunosuppressant/immunomodulator (i.e., cyclosporine, chemotherapeutic agent,
or biologic therapy)

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study


- At least 3 months since prior and no concurrent coumadin or other systemic
anticoagulant other than aspirin

- At least 30 days since prior participation and no concurrent enrollment or planning
to enroll in another clinical trial

- No non-steroidal anti-inflammatory drugs (NSAIDs) for more than 5 days per month
within the past 3 months and no concurrent non-study NSAIDs, except low dose aspirin
(81 mg/day)

- Willing or able to refrain from herbal medicines, above-standard vitamins, or
minerals during study

- Standard daily multivitamin/mineral supplement (i.e., therapeutic doses of
calcium and vitamin D for osteoporosis) allowed

- No concurrent lithium, phenytoin, or sulfonamides

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Sulindac Concentration in the Nevi (Moles)

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

H. H. Sherry Chow, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona


United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Precancerous Condition
  • precancerous condition
  • Melanoma
  • Precancerous Conditions



Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Stanford Cancer Center Stanford, California  94305-5824