MelanomaPhase 2NCT01782508
A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma
A Phase 2 study testing imatinib and Interferon in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- imatinib and Interferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Lu Si, MD, +86(10)88196951, silu.net@hotmail.com
Lu Si, MD
About this study
Official title: A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma
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.
- Conditions
- Melanoma
- Being tested
- imatinib, Interferon
- Keywords
- melanoma,adjuvant therapy,kit mutated melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinibDrug
Also called gleevec
a selectively inhibits the KIT protein tyrosine
InterferonDrug
Also called Intron
Interferon belongs to the large class of glycoproteins known as cytokines.
| Study group | Role | What they receive |
|---|---|---|
| imatinib | Experimental | Participants will take 400mg tablets once daily for one year Receives: Drug: imatinib |
| inteferon | Active comparator | Participants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months Receives: Drug: Interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse free survival
Measured: participants will be followed for the duration of hospital stay, an expected average of 18 months
Secondary outcomes (1)
overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Si, Peking University Cancer Hospital & Institute
- Investigators
- Jun Guo, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782508
- Sponsor's protocol ID
- AMN107A2301
- Status last verified
- Jan 2013
- First submitted
- 15 Aug 2012
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma
- ClinicalTrials.gov ID
- NCT01782508
- Acronym / sponsor ID
- AMN107A2301
- Conditions
- Melanoma
- Keywords
- melanoma,adjuvant therapy,kit mutated melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| imatinib | Experimental | Drug: imatinibParticipants will take 400mg tablets once daily for one year |
| inteferon | Active comparator | Drug: InterferonParticipants will receive Interferon 1500wiu/m2 d1-5for 4 weeks followed by 900wiu IH TIW for 11 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imatinibAlso: gleeveca selectively inhibits the KIT protein tyrosine | Drug | imatinib |
| InterferonAlso: IntronInterferon belongs to the large class of glycoproteins known as cytokines. | Drug | inteferon |
Primary outcome
relapse free survival
Time frame: participants will be followed for the duration of hospital stay, an expected average of 18 months
1 secondary outcome
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Guo, M.D. principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing imatinib and Interferon in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Si, MD (+86(10)88196951, silu.net@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse free survival (time frame: participants will be followed for the duration of hospital stay, an expected average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.