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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
N/A
Open (Enrolling)
Both
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
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

Type of Study:

Interventional

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:

No

Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

06-056

NCT ID:

NCT00424515

Start Date:

July 2006

Completion Date:

June 2013

Related Keywords:

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

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
H. Lee Moffitt Cancer CenterTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
University of Colorado at Denver Health Sciences CenterDenver, Colorado  80045