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Spots Global Cancer Trial Database for Study of RAD001 in Adenoid Cystic Carcinoma

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Trial Identification

Brief Title: Study of RAD001 in Adenoid Cystic Carcinoma

Official Title: Phase II Study of RAD001monotherapy in Patients With Unresectable Adenoid Cystic Carcinoma

Study ID: NCT01152840

Interventions

RAD001

Study Description

Brief Summary: * Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma. * In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data). * So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to evaluate the efficacy of RAD001 in this orphan disease.

Detailed Description: Although the histologic appearance of adenoid cystic carcinoma is low grade, management of this malignancy is a distinct therapeutic challenge because of its insidious local growth pattern, propensity for perineural involvement, tendency for distant metastasis, and pronounced ability to recur over a prolonged period. In prospectively performed clinical trials, objective responses to any cytotoxic agent or regimen are infrequent, whereas stabilization of disease was observed more commonly. In adenoid cystic carcinoma, the study focusing on PI3-K/AKT/mTOR pathway is rare. According to Younes MN et al's study, adenoid cystic carcinoma cell lines have increased pAkt activity when EGF-stimulation is added. And when treated with EGFR/VEGFR TK dual inhibitor, the phosphorylated form of Akt decreased despite of total level of Akt is remained unchanged. When the investigators consider that the increased pAkt activity is one of possible predictor to mTOR inhibitor, the mTOR inhibitor might have an activity in adenoid cystic carcinoma. Although mTOR is clearly an attractive therapeutic target in tumor, no clinical study on mTOR inhibition by RAD001 has been systematically conducted in adenoid cystic carcinoma. In phase I study of RAD001, 2 patients with adenoid cystic carcinoma show some response to RAD001 (unpublished data). So the investigators design this phase II study of RAD001 in adenoid cystic carcinoma to evaluate the efficacy of RAD001 in this orphan disease.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Seoul National University Hospital, Seoul, , Korea, Republic of

Contact Details

Name: Yung-Jue Bang, MD, PhD

Affiliation: Seoul National University Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Do-Youn Oh, MD,PhD

Affiliation: Seoul National University Hospital

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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