Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate

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