NCT00045669

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

September 6, 2002

Last Update Submit

February 13, 2019

Conditions

Head and Neck Cancer

Keywords

recurrent salivary gland cancersalivary gland adenoid cystic carcinomastage III salivary gland cancerstage IV salivary gland cancer

Study Arms (1)

Imatinib Mesylate

EXPERIMENTAL

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

Drug: imatinib mesylate

Interventions

imatinib mesylateDRUG
Imatinib Mesylate

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (15)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

LaGrange Memorial Hospital

LaGrange, Illinois, 60525, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Related 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 Clin Oncol. 2005 Jan 20;23(3):585-90. doi: 10.1200/JCO.2005.06.125.

    PMID: 15659505RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSalivary Gland Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • George P. Browman, MD

    Margaret and Charles Juravinski Cancer Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Primary Completion

January 1, 2004

Study Completion

January 1, 2005

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

CA(1)US(14)