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

Primary Purpose

Mucosal Melanoma, Acral/Lentiginous Melanoma, Chronically Sun Damaged Melanomas

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Imatinib
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucosal Melanoma focused on measuring Imatinib, Gleevec

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado at Denver Health Sciences Center
  • H. Lee Moffitt Cancer Center
  • University of Chicago
  • Dana-Farber Cancer Institute
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Imatinib

Outcomes

Primary Outcome Measures

Best Overall Response
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.

Secondary Outcome Measures

Time to Progression
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
Overall survival (OS) is defined as the time from study entry to death or date last known alive.

Full Information

First Posted
January 18, 2007
Last Updated
October 16, 2016
Sponsor
Dana-Farber Cancer Institute
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00424515
Brief Title
Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
Acronym
BUS255
Official Title
A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucosal Melanoma, Acral/Lentiginous Melanoma, Chronically Sun Damaged Melanomas
Keywords
Imatinib, Gleevec

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Imatinib
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best Overall Response
Description
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.
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).
Secondary Outcome Measure Information:
Title
Time to Progression
Description
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.
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).
Title
Overall Survival
Description
Overall survival (OS) is defined as the time from study entry to death or date last known alive.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Stephen Hodi, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Denver Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23775962
Citation
Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, Friedlander P, Gonzalez R, Weber JS, Gajewski TF, O'Day SJ, Kim KB, Lawrence D, Flaherty KT, Luke JJ, Collichio FA, Ernstoff MS, Heinrich MC, Beadling C, Zukotynski KA, Yap JT, Van den Abbeele AD, Demetri GD, Fisher DE. Imatinib for melanomas harboring mutationally activated or amplified KIT arising on mucosal, acral, and chronically sun-damaged skin. J Clin Oncol. 2013 Sep 10;31(26):3182-90. doi: 10.1200/JCO.2012.47.7836. Epub 2013 Jun 17.
Results Reference
background
PubMed Identifier
25609545
Citation
Zukotynski K, Yap JT, Giobbie-Hurder A, Weber J, Gonzalez R, Gajewski TF, O'Day S, Kim K, Hodi FS, Van den Abbeele AD. Metabolic response by FDG-PET to imatinib correlates with exon 11 KIT mutation and predicts outcome in patients with mucosal melanoma. Cancer Imaging. 2014 Nov 12;14(1):30. doi: 10.1186/s40644-014-0030-0.
Results Reference
derived

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Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

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