A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma

NCT01782508 | Unknown Phase 2 DMC

• 1 other identifier: AMN107A2301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the relapse free survival and overall survival of Imatinib (Gleevec) or high dose Interferon (Intron) in treating melanoma which has primary tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit mutation. It is assumed that Gleevec may be more effective on relapse free survival as the adjuvant treatment compared with Interferon.

Conditions

Melanoma

Keywords

melanoma,adjuvant therapy,kit mutated melanoma

Outcome Measures

Primary Outcomes (1)

• relapse free survival

  participants will be followed for the duration of hospital stay, an expected average of 18 months

Secondary Outcomes (1)

• overall survival

  From date of randomization until the date of death from any cause, assessed up to 48 months

Study Arms (2)

imatinib

EXPERIMENTAL

Participants will take 400mg tablets once daily for one year

Drug: imatinib

inteferon

ACTIVE COMPARATOR

Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months

Drug: Interferon

Interventions

imatinib DRUG

a selectively inhibits the KIT protein tyrosine

Also known as: gleevec

imatinib

Interferon DRUG

Interferon belongs to the large class of glycoproteins known as cytokines.

Also known as: Intron

inteferon

Eligibility Criteria

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

You may qualify if:

• Melanoma patients whose primary tumor and regional lymphonodes (if have)have been resected
• Histologically documented AJCC stage IIB to IIIC
• C-kit mutation documented from either primary or metastatic lymphnode site
• ECOG performance status 0 or 1
• 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
• no prior chemotherapy or investigational drug

You may not qualify if:

• Severe and/or uncontrolled medical disease
• Pregnant or nursing mothers
• Any other significant medical, surgical, or psychiatric condition that may 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 chronic liver disease
• Known diagnosis of HIV infection
• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Imatinib Mesylate; Interferons; Introns

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; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Jun Guo, M.D.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Si, MD

CONTACT

+86(10)88196951; silu.net@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: February 4, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

CN (1)