Imatinib Mesylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

NCT00470470 | Completed Phase 2 Results

• 8 other identifiers: NCI-2009-00216CDR0000543404MSKCC-0701407-0147754P30CA008748N01CM62206N01CM62204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

Brief Summary

This phase II trial is studying how well imatinib mesylate works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Acral Lentiginous Malignant Melanoma; Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon two-stage minimax design will be employed.

  Every 6 weeks for the first 3 courses and then every 12 weeks thereafter

Secondary Outcomes (1)

• Time to Progression

  Time from the treatment start to the date of disease progression

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive oral imatinib mesylate twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylate; Other: laboratory biomarker analysis

Interventions

imatinib mesylate DRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed inoperable stage III or IV melanoma that began on acral skin or mucosa
• Patients with cutaneous melanoma that began on sun exposed sites of the skin and whose pathology demonstrates signs of sun damage (solar elastosis) involving the skin surrounding their primary melanoma are eligible
• Must have sufficient tumor tissue available for FISH and DNA sequencing
• Patients must have either a true amplification of 4q12 or a detectable mutation of c-KIT
• If no banked tumor tissue is available, or if the available banked tumor tissue is insufficient for the necessary testing, then a repeat biopsy procedure will be required to collect the necessary tumor sample
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• No known untreated brain or epidural metastases
• Brain metastases that have been treated and deemed stable are allowed
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy greater than 3 months
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Patients with unexplained hyperbilirubinemia that is clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert's syndrome) may be eligible

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (8)

University of California at Los Angeles (UCLA )

Los Angeles, California, 90095, United States

Location

Mount Sinai Medical Center CCOP

Miami Beach, Florida, 33140, United States

Location

Good Samaritan Medical Center

West Palm Beach, Florida, 33401, United States

Location

Palm Beach Cancer Institute-Main Office

West Palm Beach, Florida, 33401, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Related Publications (1)

• Carvajal RD, Antonescu CR, Wolchok JD, Chapman PB, Roman RA, Teitcher J, Panageas KS, Busam KJ, Chmielowski B, Lutzky J, Pavlick AC, Fusco A, Cane L, Takebe N, Vemula S, Bouvier N, Bastian BC, Schwartz GK. KIT as a therapeutic target in metastatic melanoma. JAMA. 2011 Jun 8;305(22):2327-34. doi: 10.1001/jama.2011.746.

  PMID: 21642685 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr. Richard Carvajal
• Organization: Memorial Sloan-Kettering Cancer Center

carvajar@mskcc.org

646-888-4161

Study Officials

• Richard Carvajal

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: October 1, 2014
• Last Updated: December 23, 2014
• Results First Posted: December 23, 2014

Record last verified: 2014-01

Locations

US (8)