A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
OBJECTIVES:
- Determine the antitumor activity of imatinib mesylate, in terms of objective response
rates (partial and complete responses) and duration of overall response, in patients
with unresectable and/or metastatic adenoid cystic, lymphoepithelioma-like, or
myoepithelial salivary gland cancer.
- Determine the safety and tolerability of this drug in these patients.
- Correlate the activity of c-kit and downstream kinases in pre- and post-treatment
tumoral biopsies with clinical course in patients treated with this drug.
- Determine the effect of treatment with this drug on tumor samples from these patients
in terms of proliferation, apoptosis, and angiogenesis.
- Correlate the steady state levels of this drug achieved with clinical and laboratory
correlative endpoints in these patients.
- Determine whether early changes in metabolic activity correlate with molecular changes
and predict outcome to therapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate twice daily. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Patients with stable disease
receive treatment for up to 6 months.
Patients are followed within 3 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenoid cystic, lymphoepithelioma-like, or
myoepithelial salivary gland cancer
- Unresectable AND/OR
- Radiologically documented metastatic disease
- c-kit positive tumor (1+, 2+, or 3+)
- At least 1 unidimensionally measurable lesion
- More than 20 mm by conventional techniques OR
- More than 10 mm by spiral CT scan
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 12 weeks
Hematopoietic
- Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic
- Bilirubin less than 1.25 times upper limit of normal (ULN)
- AST/ALT less than 2.5 times ULN
Renal
- Creatinine less than 1.25 times ULN OR
- Creatinine clearance greater than 50 mL/min
Cardiovascular
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No unstable angina
- No active cardiomyopathy
- No unstable ventricular arrhythmias
- No uncontrolled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months
after study
- No other active malignancy within the past 5 years except adequately treated
carcinoma in situ of the cervix or non-melanomatous skin cancer
- No uncontrolled psychotic disorders
- No serious infections
- No active peptic ulcer disease
- No other serious medical condition that would preclude study
- No prior allergy to compounds of similar chemical or biologic composition as imatinib
mesylate
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent filgrastim (G-CSF)
Chemotherapy
- At least 4 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy to sites of measurable disease
Surgery
- At least 4 weeks since prior surgery and recovered
Other
- No other concurrent investigational agents
- No concurrent therapeutic warfarin
- Mini-dose warfarin for prophylaxis or low-molecular weight heparin allowed
- No concurrent erythromycin
- No concurrent acetaminophen doses exceeding 3 g/day
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
George P. Browman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Margaret and Charles Juravinski Cancer Centre
Authority:
United States: Federal Government
Study ID:
CDR0000257029
NCT ID:
NCT00045669
Start Date:
July 2002
Completion Date:
January 2005
Related Keywords:
- Head and Neck Cancer
- recurrent salivary gland cancer
- salivary gland adenoid cystic carcinoma
- stage III salivary gland cancer
- stage IV salivary gland cancer
- Head and Neck Neoplasms
- Salivary Gland Neoplasms
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
| Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
| Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
| Evanston Northwestern Health Care - Evanston Hospital | Evanston, Illinois 60201 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
| Siteman Cancer Center | Saint Louis, Missouri 63110 |
| LaGrange Memorial Hospital | LaGrange, Illinois 60525 |
