NCT01058408

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

January 26, 2010

Last Update Submit

February 20, 2013

Conditions

Head and Neck Cancer

Keywords

advanced head and neck cancercisplatinRAD001radiationHNSCC

Outcome Measures

Primary Outcomes (1)

  • To evaluate the maximum tolerated dose (MTD) and safety of the RAD001 in combination with weekly cisplatin and radiation in patients with locally advanced HNSCC.

    2 years

Secondary Outcomes (1)

  • Obtain preliminary results on efficacy of the RAD001, cisplatin and radiation therapy combination in patients with locally advanced HNSCC.

    3 years

Study Arms (1)

Rad001 with cisplatin

EXPERIMENTAL
Radiation: Intensity modulated radiotherapyDrug: RAD001Drug: cisplatin

Interventions

Intensity modulated radiotherapyRADIATION

Administered daily 5 days per week

Also known as: IMRT
Rad001 with cisplatin
RAD001DRUG

Taken orally once a day

Rad001 with cisplatin
cisplatinDRUG

Administered intravenously once a week

Rad001 with cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stage III/IV, locally advanced, biopsy proven squamous cell cancer of the head and neck who are planned to undergo chemoradiation as their primary treatment with curative intent. Patients with oropharynx, hypopharynx, larynx primaries, nasopharynx as well as those with documented SCC of the cervical lymph nodes, with unknown primaries, are eligible.
  • Patients must have at least evaluable disease and one measurable site of disease according to RECIST criteria is desirable.
  • years of age or older
  • Minimum of two weeks since any major surgery
  • WHO performance status of 2 or less
  • Adequate bone marrow, liver, and renal function as outlined in the protocol

You may not qualify if:

  • Presence of distant metastatic disease
  • Prior chemotherapy
  • Prior radiation to the head and neck or adjacent anatomical site
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the thyroid, cervix or basal or squamous cell carcinomas of the skin
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Uncontrolled diabetes mellitus
  • A known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
  • Women who are pregnant or breastfeeding, or women/men able to conceive and unwilling to practice an effective method of birth control
  • Patients who have received prior treatment with an mTOR inhibitor
  • Patients with a known hypersensitivity to RAD001 or other rapamycins or to its excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

Radiotherapy, Intensity-ModulatedEverolimusCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsSirolimusMacrolidesLactonesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Jochen Lorch, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncology

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 28, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

US(1)