search
Back to results

Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent salivary gland cancer, salivary gland adenoid cystic carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Decatur Memorial Hospital Cancer Care Institute
  • Evanston Northwestern Health Care - Evanston Hospital
  • Ingalls Memorial Hospital
  • LaGrange Memorial Hospital
  • Loyola University Medical Center
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Lakeland Medical Center - St. Joseph
  • Siteman Cancer Center
  • University of Wisconsin Comprehensive Cancer Center
  • Cancer Care Ontario-Hamilton Regional Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib Mesylate

Arm Description

Adult patients with unresectable or metastatic adenoid cystic carcinoma measurable by Response Evaluation Criteria in Solid Tumors Group criteria and expressing c-kit by immunohistochemistry were treated with imatinib 400 mg orally bid. Response was assessed every 8 weeks

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
February 13, 2019
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00045669
Brief Title
Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
Official Title
A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
recurrent salivary gland cancer, salivary gland adenoid cystic carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imatinib Mesylate
Arm Type
Experimental
Arm Description
Adult patients with unresectable or metastatic adenoid cystic carcinoma measurable by Response Evaluation Criteria in Solid Tumors Group criteria and expressing c-kit by immunohistochemistry were treated with imatinib 400 mg orally bid. Response was assessed every 8 weeks
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George P. Browman, MD
Organizational Affiliation
Margaret and Charles Juravinski Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
LaGrange Memorial Hospital
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Lakeland Medical Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15659505
Citation
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 Clin Oncol. 2005 Jan 20;23(3):585-90. doi: 10.1200/JCO.2005.06.125.
Results Reference
result

Learn more about this trial

Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

We'll reach out to this number within 24 hrs