Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (BUS255)

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Mucosal Melanoma

Acral/Lentiginous Melanoma

Chronically Sun Damaged Melanomas

Treatments

Drug: Imatinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00424515

06-056

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
To determine the time to progression.

Secondary

To correlate c-kit mutational status with response to therapy.
To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
Tolerability of imatinib.
To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
To correlate c-kit amplification status with response to therapy.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 < 1.5 x ULN
ANC > 1500 ul
Platelets > 100,000 ul
Total bilirubin, AST, and ALT < 2 x ULN
Amylase and lipase < 1.5 x ULN
C-kit mutation documented from either primary or metastatic tumor site
> 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 < 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ
Concurrent treatment with Warfarin
Prior treatment with c-kit inhibitor
Patient with Grade III/IV cardiac problems as defined by NYHA criteria
No H2 blockers or proton pump inhibitors
Known brain metastasis
Known chronic liver disease
Known diagnosis of HIV infection
Previous radiotherapy to > 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