Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (BUS255)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00424515
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 18, 2007
First Posted Date  ICMJE January 19, 2007
Results First Submitted Date  ICMJE August 22, 2016
Results First Posted Date  ICMJE December 8, 2016
Last Update Posted Date December 8, 2016
Study Start Date  ICMJE July 2006
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2016)
Best Overall Response [ Time Frame: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). ]
Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
To determine the response rate of patients with metastatic mucosal or acral/lentiginous melanoma to treatment with Gleevec and also to determine the time to progression.
Change History Complete list of historical versions of study NCT00424515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2016)
  • Time to Progression [ Time Frame: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). ]
    Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
  • Overall Survival [ Time Frame: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1). ]
    Overall survival (OS) is defined as the time from study entry to death or date last known alive.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2007)
  • To correlate c-kit mutational status with response to therapy
  • to evaluate the tolerability of Gleevec in this patient population.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
Official Title  ICMJE A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.
Brief Summary The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.
Detailed Description

OBJECTIVES:

Primary

  • To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
  • To determine the time to progression.

Secondary

  • To correlate c-kit mutational status with response to therapy.
  • To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
  • Tolerability of imatinib.
  • To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
  • To correlate c-kit amplification status with response to therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mucosal Melanoma
  • Acral/Lentiginous Melanoma
  • Chronically Sun Damaged Melanomas
Intervention  ICMJE Drug: Imatinib
Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.
Other Name: Gleevec
Study Arms  ICMJE Experimental: Treatment Arm
Imatinib
Intervention: Drug: Imatinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2013)
24
Original Enrollment  ICMJE
 (submitted: January 18, 2007)
34
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis
  • History of primary mucosal or acral/lentiginous melanoma
  • Histologically documented stage IV metastatic melanoma
  • ECOG performance status 0,1, or 2
  • Estimated life expectancy of 6 months or greater
  • 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
  • C-kit mutation documented from either primary or metastatic tumor site
  • > 4 weeks from prior chemotherapy or investigational drug
  • At least one measurable site of disease as defined by at least 1 cm in greatest dimension

Exclusion Criteria:

  • Severe and/or uncontrolled medical disease
  • Pregnant or nursing mothers
  • Any other significant medical, surgical, or psychiatric condition that my 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 brain metastasis
  • Known chronic liver disease
  • Known diagnosis of HIV infection
  • Previous radiotherapy to > 25% of the bone marrow
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424515
Other Study ID Numbers  ICMJE 06-056
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party F. Stephen Hodi, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP