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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00700882 |
Purpose
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Drug: dasatinib Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Dasatinib in Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas |
| Estimated Enrollment: | 87 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tissue samples may be collected from some patients for correlative studies.
After completion of study therapy, patients are followed up periodically for up to 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma of 1 of the following subtypes:
c-KIT mutation identified by polymerase chain reaction (PCR) and sequencing meeting 1 of the following criteria:
Measurable disease, defined as at least one measurable lesion by RECIST criteria
History or clinical evidence of brain metastasis allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
INR ≤ 1.5 and PTT normal
Patients must not have any clinically significant cardiovascular disease including the following:
No uncontrolled hypertension, defined as systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemotherapy or immunotherapy
Contacts and Locations| United States, Iowa | |
| McFarland Clinic, PC | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Contact: Clinical Trials Office - McFarland Clinic, PC 515-239-2621 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Joseph P. Lynch, MD 918-494-8275 | |
| Study Chair: | Donald P. Lawrence, MD | Massachusetts General Hospital |
| Investigator: | Kevin Kalinsky, MD | Tufts Medical Center Cancer Center |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00700882 History of Changes |
| Other Study ID Numbers: | CDR0000598300, ECOG-E2607 |
| Study First Received: | June 18, 2008 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Unspecified |
|
stage IV melanoma acral lentiginous malignant melanoma mucosal melanoma recurrent melanoma |
stage IIIA melanoma stage IIIB melanoma stage IIIC melanoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |