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Completed

NCT Number: NCT00424515

Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma

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.

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Key information

Conditions

Mucosal Melanoma Acral/Lentiginous Melanoma Chronically Sun Damaged Melanomas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado at Denver Health Sciences Center, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imatinib

Drug

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 names: Gleevec

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Novartis

Registry information

Official study title

A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.

Acronym: BUS255

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 19, 2007
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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