Phase 2 N=24 Treatment

Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

Mucosal Melanoma · Acral/Lentiginous Melanoma · Chronically Sun Damaged Melanomas

Bottom Line

View on ClinicalTrials.gov: NCT00424515 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Dec 2016

Primary outcome: Primary: Best Overall Response — 0; 0; 0; 7 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Imatinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dana-Farber Cancer Institute
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Best Overall Response	0; 0; 0; 7; 2; 3	—
SECONDARY Time to Progression	3.4; 3.9	—
SECONDARY Overall Survival	11.9; 12.9	—

Summary

The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.

Eligibility Criteria

Inclusion Criteria

Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis
History of primary mucosal or acral/lentiginous melanoma
Histologically documented stage IV metastatic melanoma
ECOG performance status 0,1, or 2
Estimated life expectancy of 6 months or greater
Age 18 years or older
Creatinine 1500 ul
Platelets > 100,000 ul
Total bilirubin, AST, and ALT 4 weeks from prior chemotherapy or investigational drug
At least one measurable site of disease as defined by at least 1 cm in greatest dimension

Exclusion Criteria

Severe and/or uncontrolled medical disease
Pregnant or nursing mothers
Any other significant medical, surgical, or psychiatric condition that my interfere with compliance
Patient is 25% of the bone marrow
Major surgery within 2 weeks prior to study entry
Patient has received any other investigational agent within 28 days of first study drug dosing
Chemotherapy within 4 weeks prior to study entry

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00424515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.