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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00180921
First received: September 13, 2005
Last updated: September 24, 2007
Last verified: September 2006

September 13, 2005
September 24, 2007
July 2004
Not Provided
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 ]
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.
Complete list of historical versions of study NCT00180921 on ClinicalTrials.gov Archive Site
The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.
The secondary objective are to estimate the objective response rate (RECIST criteria), the disease control and the overall survival.
Not Provided
Not Provided
 
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer of the Head and Neck
  • Carcinoma, Adenoid Cystic
Drug: Imatinib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
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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
Both
18 Years and older
No
Contact: Sandrine Faivre, MD 33 1 40 87 50 25 s.faivre@bjn.aphp.fr
France
 
NCT00180921
CSTI BFR 17
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Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Principal Investigator: Sandrine Faivre, MD Centre Hospitalier de Beaujon
Gustave Roussy, Cancer Campus, Grand Paris
September 2006

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