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Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck

Primary Purpose

Cancer of the Head and Neck, Carcinoma, Adenoid Cystic

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Imatinib
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Head and Neck focused on measuring Adenoid cystic carcinoma of the head and neck

Eligibility Criteria

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

Inclusion Criteria: Histologically or cytologically proven adenoid cystic carcinoma overexpressing KIT (by immunohistochemistry) with recurrent disease documented by computed tomography (CT) scan or magnetic resonance imaging (MRI). Presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter >= 2 cm, based on CT or MRI scan done within 4 weeks before the start of treatment). Patients able to swallow an oral compound. World Health Organization (WHO) performance status < 2. Life expectancy of >= 3 months. Aged >= 18 years. Normal hematological (neutrophils >= 1.5 x 10^9 cells/l, platelets >= 100 x 10^9 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases <= 2.5 x the upper limit of the normal range) and renal (serum creatinine <= 150 mmol/l) functions. Written informed consent. Exclusion Criteria: Abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ECG). Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma. Concomitant treatment with warfarin or any other anticoagulants. Unstable systemic diseases or active uncontrolled infections. Patients (male and female) not using effective contraception if of reproductive potential. Females pregnant or lactating or positive beta human chorionic gonadotropin (bHCG) at baseline

Sites / Locations

  • Institut Gustave RoussyRecruiting

Outcomes

Primary Outcome Measures

To assess progression-free survival under treatment with imatinib mesylate in patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.

Secondary Outcome Measures

The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.

Full Information

First Posted
September 13, 2005
Last Updated
September 24, 2007
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00180921
Brief Title
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
Official Title
Phase II Study of Imatinib (Glivec) Administered as a Daily Oral Treatment in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck Overexpressing KIT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

Brief Summary
This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.
Detailed Description
Patients with relapsing and/or metastatic adenoid cystic carcinoma of the salivary gland of the head and neck are usually poor responders to conventional cytotoxic chemotherapy. The investigation of proliferation pathways involving tyrosine kinase receptors such as c-kit receptor (KIT) and PDGF receptor may allow to identify a molecular target for novel therapeutic approaches in patients with adenoid cystic carcinoma who failed locoregional treatment. Several publications in the literature and the pathological study we conducted in Institut Gustave Roussy show that KIT overexpression is observed in at least 80-90% of the cases of adenoid cystic carcinoma, supporting the investigation of imatinib in patients with adenoid cystic carcinoma overexpressing KIT. Imatinib is an orally administrated, well tolerated compound that could be given on an outpatient schedule to patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck. Because of the infrequent occurrence of salivary gland malignancies, a multicenter trial will be mandatory and the study will include at least 2 centers represented by Institut Gustave Roussy, Villejuif; and Hôpital Georges-Pompidou, Paris.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Head and Neck, Carcinoma, Adenoid Cystic
Keywords
Adenoid cystic carcinoma of the head and neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imatinib
Primary Outcome Measure Information:
Title
To assess progression-free survival under treatment with imatinib mesylate in patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven adenoid cystic carcinoma overexpressing KIT (by immunohistochemistry) with recurrent disease documented by computed tomography (CT) scan or magnetic resonance imaging (MRI). Presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter >= 2 cm, based on CT or MRI scan done within 4 weeks before the start of treatment). Patients able to swallow an oral compound. World Health Organization (WHO) performance status < 2. Life expectancy of >= 3 months. Aged >= 18 years. Normal hematological (neutrophils >= 1.5 x 10^9 cells/l, platelets >= 100 x 10^9 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases <= 2.5 x the upper limit of the normal range) and renal (serum creatinine <= 150 mmol/l) functions. Written informed consent. Exclusion Criteria: Abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ECG). Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma. Concomitant treatment with warfarin or any other anticoagulants. Unstable systemic diseases or active uncontrolled infections. Patients (male and female) not using effective contraception if of reproductive potential. Females pregnant or lactating or positive beta human chorionic gonadotropin (bHCG) at baseline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandrine Faivre, MD
Phone
33 1 40 87 50 25
Email
s.faivre@bjn.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine Faivre, MD
Organizational Affiliation
Centre Hospitalier de Beaujon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine Faivre, MD
Phone
33 1 40 87 50 25
Email
s.faivre@bjn.aphp.fr
First Name & Middle Initial & Last Name & Degree
Caroline Robert, MD
Phone
33 1 42 11 42 53
Email
crobert@igr.fr

12. IPD Sharing Statement

Learn more about this trial

Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck

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