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RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer

NCT01058408 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2013-02-22

No results posted yet for this study

Summary

RAD001 is approved by the U.S Food and Drug Administration (FDA) to treat advanced kidney cancer. This drug has also been used in other research studies to evaluate its effectiveness in other cancers. Information from these research studies suggests that RAD001 may help to decrease the growth and development of tumor cells by reducing the blood supply that tumors need to grow. In this research study, we are trying to determine the safety of RAD001 when given to people with locally advanced head and neck cancer in combination with cisplatin and radiation. We are also looking for the highest dose of RAD001 that can be given to people safely.

Conditions

Interventions

RADIATION

Intensity modulated radiotherapy

Administered daily 5 days per week

DRUG

RAD001

Taken orally once a day

DRUG

cisplatin

Administered intravenously once a week

Sponsors & Collaborators

Principal Investigators

  • Jochen Lorch, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01058408 on ClinicalTrials.gov