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A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 CenterChicago, Illinois  60637
Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Evanston Northwestern Health Care - Evanston HospitalEvanston, Illinois  60201
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Siteman Cancer CenterSaint Louis, Missouri  63110
LaGrange Memorial HospitalLaGrange, Illinois  60525