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Status unknownNCT01782508Updated Feb 4, 2013

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

A Phase 2 interventional study of imatinib and Interferon in Melanoma, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-04.

Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Melanoma

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Keywords

  • melanoma,adjuvant therapy,kit mutated melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 40 is close to the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    imatinib

    Participants will take 400mg tablets once daily for one year

    Drug: imatinib

  • Active comparator
    inteferon

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

    Drug: Interferon

Interventions

  • Drugimatinib

    a selectively inhibits the KIT protein tyrosine

    Also known as: gleevec

  • DrugInterferon

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

    Also known as: Intron

06

What researchers measure

Primary outcomes

  1. relapse free survival

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

Secondary outcomes

  1. overall survival

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

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Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, 100142, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01782508
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
Lu Si (Associate professor, Peking University Cancer Hospital & Institute) — Principal investigator
First posted
Feb 4, 2013
Start date
Aug 2012
Primary completion
Dec 2013 (estimated)
Completion
Dec 2014 (estimated)
Last update
Feb 4, 2013

Study contacts

Lu Si, MD
Contact
silu.net@hotmail.com
+86(10)88196951
Jun Guo, M.D.
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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