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

Phase 2
18 Years
Open (Enrolling)
Mucosal Melanoma, Acral/Lentiginous Melanoma, Chronically Sun Damaged Melanomas

Thank you

Trial Information

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

- If tests show that the patient is eligible and they choose to participate in the study,
they will receive a bottle of Gleevec pills. Each pill will be 100mg and the
participant will take 4 pills once daily (400mg). The dose may increase to 400mg twice
a day if the participant's cancer worsens.

- The following study procedures will also be performed at routine intervals throughout
the course of treatment: blood tests, medical history updates; physical exams, Positron
Emission tomography (PET) scan, and Chest/Abdomen/Pelvic CT.

- Participants will be on this study for approximately one year.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate of patients with metastatic mucosal or acral/lentiginous melanoma and chronically sundamaged melanomas to treatment with Gleevec and also to determine the time to progression.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

June 2013

Related Keywords:

  • Mucosal Melanoma
  • Acral/Lentiginous Melanoma
  • Chronically Sun Damaged Melanomas
  • Imatinib
  • Gleevec
  • Melanoma



MD Anderson Cancer Center Houston, Texas  77030-4096
Dana-Farber Cancer Institute Boston, Massachusetts  02115
H. Lee Moffitt Cancer Center Tampa, Florida  33612
University of Chicago Chicago, Illinois  60637
University of Colorado at Denver Health Sciences Center Denver, Colorado  80045