Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (BUS255)
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Novartis
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00424515
First received: January 18, 2007
Last updated: August 8, 2012
Last verified: October 2011
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Purpose
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. Gleevec is a protein-kinase inhibitor. It is believed that Gleevec may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.
| Condition | Intervention | Phase |
|---|---|---|
|
Mucosal Melanoma Acral/Lentiginous Melanoma Chronically Sun Damaged Melanomas |
Drug: Imatinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To correlate c-kit mutational status with response to therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- to evaluate the tolerability of Gleevec in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 27 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Imatinib
Participants will take four 100mg tablets once daily for approximately one year (Dosage may be increased to twice daily if disease worsens)
Other Name: Gleevec
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424515
Locations
| United States, Colorado | |
| University of Colorado at Denver Health Sciences Center | |
| Denver, Colorado, United States, 80045 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Novartis
Investigators
| Principal Investigator: | F. Stephen Hodi, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | F. Stephen Hodi, MD, Melanoma Disease Center Director, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00424515 History of Changes |
| Other Study ID Numbers: | 06-056 |
| Study First Received: | January 18, 2007 |
| Last Updated: | August 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
Imatinib Gleevec |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013