Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

NCT ID: NCT00424515

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2011-07-31

Brief 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.

Detailed 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.

Conditions

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

Keywords

Imatinib; Gleevec

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Imatinib

Group Type: EXPERIMENTAL

Imatinib

Intervention Type: DRUG

Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.

Interventions

Imatinib

Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.

Intervention Type: DRUG

Other Intervention Names

Gleevec

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 < 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

F. Stephen Hodi, MD

Melanoma Disease Center Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

F. Stephen Hodi, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

University of Colorado at Denver Health Sciences Center

Denver, Colorado, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, Friedlander P, Gonzalez R, Weber JS, Gajewski TF, O'Day SJ, Kim KB, Lawrence D, Flaherty KT, Luke JJ, Collichio FA, Ernstoff MS, Heinrich MC, Beadling C, Zukotynski KA, Yap JT, Van den Abbeele AD, Demetri GD, Fisher DE. Imatinib for melanomas harboring mutationally activated or amplified KIT arising on mucosal, acral, and chronically sun-damaged skin. J Clin Oncol. 2013 Sep 10;31(26):3182-90. doi: 10.1200/JCO.2012.47.7836. Epub 2013 Jun 17.

Reference Type: BACKGROUND

PMID: 23775962 (View on PubMed)

Zukotynski K, Yap JT, Giobbie-Hurder A, Weber J, Gonzalez R, Gajewski TF, O'Day S, Kim K, Hodi FS, Van den Abbeele AD. Metabolic response by FDG-PET to imatinib correlates with exon 11 KIT mutation and predicts outcome in patients with mucosal melanoma. Cancer Imaging. 2014 Nov 12;14(1):30. doi: 10.1186/s40644-014-0030-0.

Reference Type: DERIVED

PMID: 25609545 (View on PubMed)

Other Identifiers

06-056

Identifier Type: -

Identifier Source: org_study_id