Phase 2 Completed N=24 Treatment

Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

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

Source: ClinicalTrials.gov NCT00424515 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Dec 2016

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

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.

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	—

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. Informational only — not medical advice.