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

September 24, 2007 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Drug: Imatinib

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Villejuif, France, 94800
    - Recruiting
    - Institut Gustave Roussy
    - Contact:
      
      Sandrine Faivre, MD
      
      Phone Number: 33 1 40 87 50 25
      
      Email: s.faivre@bjn.aphp.fr
    - Contact:
      
      Caroline Robert, MD
      
      Phone Number: 33 1 42 11 42 53
      
      Email: crobert@igr.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	at 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

Principal Investigator: Sandrine Faivre, MD, Centre Hospitalier de Beaujon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria