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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 Overexpressi

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 Summary:

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.

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: 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: 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.

Current Secondary Outcome: 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: The secondary objective are to estimate the objective response rate (RECIST criteria), the disease control and the overall survival.

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: September 13, 2005
Date Started: July 2004
Date Completion:
Last Updated: September 24, 2007
Last Verified: September 2006