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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Beijing Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Lu Si, Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01782508
First received: August 15, 2012
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: imatinib
Drug: Interferon
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma

Resource links provided by NLM:


Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • relapse free survival [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: imatinib
Participants will take 400mg tablets once daily for one year
Drug: imatinib
a selectively inhibits the KIT protein tyrosine
Other Name: gleevec
Active Comparator: inteferon
Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months
Drug: Interferon
Interferon belongs to the large class of glycoproteins known as cytokines.
Other Name: Intron

Detailed Description:

If mutation tests show that the patient is eligible and they choose to participate in the study, they will be randomized and receive imatinib/Interferon. Each imatinib pill will be 100mg and the participants will take 4 pills once daily (400mg).Participants randomized to the interferon arm will receive Interferon 1500wiu/m2 d1-5 for 4 weeks followed by 900wiu IH TIW for 11 months. The following study procedures will also be performed at routine intervals throughout the course of treatment including blood tests, medical history updates, physical exams and Chest/Abdomen/Pelvic CT examinations.Participants will be on this study for one year and then be followed up to relapse or distal metastasis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782508

Contacts
Contact: Lu Si, MD +86(10)88196951 silu.net@hotmail.com

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China, 100142
Contact: Lu Si, MD    +86(10)88196951    silu.net@hotmail.com   
Sub-Investigator: Lu Si, MD         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Principal Investigator: Jun Guo, M.D. Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Lu Si, Associate professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01782508     History of Changes
Other Study ID Numbers: AMN107A2301
Study First Received: August 15, 2012
Last Updated: January 31, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Cancer Hospital:
melanoma,adjuvant therapy,kit mutated melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Imatinib
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014