Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045669
• Other study ID #: CDR0000257029
• Secondary ID: PMH-PHL-009NCI-5
• Status: Completed
• Phase: Phase 2
• Start date: July 2002
• Est. completion date: January 2005

Study information

• Verified date: February 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have unresectable and/or metastatic salivary gland cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2005
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Salivary Gland Neoplasms

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Evanston Northwestern Health Care - Evanston Hospital	Evanston	Illinois
United States	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	LaGrange Memorial Hospital	LaGrange	Illinois
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Hotte SJ, Winquist EW, Lamont E, MacKenzie M, Vokes E, Chen EX, Brown S, Pond GR, Murgo A, Siu LL. Imatinib mesylate in patients with adenoid cystic cancers of the salivary glands expressing c-kit: a Princess Margaret Hospital phase II consortium study. J — View Citation