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

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ClinicalTrials.gov Identifier: NCT00180921
Recruitment Status : Unknown
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : September 26, 2007
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date September 26, 2007
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To assess progression-free survival at 6 months under treatment with imatinib mestilate in patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2007)
The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
The secondary objective are to estimate the objective response rate (RECIST criteria), the disease control and the overall survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer of the Head and Neck
  • Carcinoma, Adenoid Cystic
Intervention  ICMJE Drug: Imatinib
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 13, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00180921
Other Study ID Numbers  ICMJE CSTI BFR 17
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandrine Faivre, MD Centre Hospitalier de Beaujon
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP