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Head and Neck CancerPhase 1NCT01057277

RAD001, Cisplatin and Concurrent Radiation for Locally Advanced, Inoperable Head and Neck Cancer

A Phase 1 study testing RAD001(Afinitor) in people with Head and Neck Cancer, run by howard safran at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if RAD001, to a maximum dose of 10 mg/day, can be safely administered with cisplatin, and concurrent radiotherapy, for patients with locally advanced, inoperable, squamous cell carcinoma of the head and neck. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
RAD001(Afinitor)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Dec 2009to Jun 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx;
  • Stage III or IV disease. Patients are unresectable or resection would produce severe impairment or disfiguration.
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
  • History/physical examination within 4 weeks prior to registration
  • Chest x-ray (or Chest CT scan or PET/CT scan) within 6 weeks prior to registration.
  • CT scan, Pet CT, or MRI of the head and neck (of the primary tumor and neck nodes).
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  • Zubrod Performance Status 0-1;
  • Age > 18;
  • Adequate bone marrow function, defined as ANC > 1,500 cells/ul and Platelets > 100,000 cells/ul and Hgb > 9mg/dl.
  • Bilirubin < 1.5x upper limit of normal, (For patients with Gilbert's disease as the sole cause of elevated bilirubin, they are eligible if the direct bilirubin is < than 1.5x upper limit of normal)
  • AST or ALT < 2.5x the upper limit of normal.
  • Adequate renal function, defined as follows:
  • Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to registration determined by:
  • 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)
  • INR and PTT < 1.5 x uln. (Anticoagulation is allowed if target INR < 1.5 on a stable dose of warfarin or a stable dose of LMW heparin for > 2 weeks prior to starting treatment.)
  • Pregnancy test within 7 days prior to administration of RAD001for women of childbearing potential.
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment); If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
  • Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication and values have been rechecked.
  • EKG within 6 weeks of study entry
  • Signed informed consent

Who cannot join

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3years.
  • Patients with simultaneous primaries or bilateral tumors are excluded. Patients with nasopharyngeal cancer and unknown primaries are excluded.
  • Gross total excision (e.g., by tonsillectomy) of the primary tumor; however, partial removal of the tumor to alleviate an impending airway obstruction does not make the patient ineligible.
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  • Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.
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  • Severe, active co-morbidity, defined as follows:
  • Current uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure.
  • Transmural myocardial infarction within the last 6 months;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration defined as oxygen saturation that is < 88% at rest on room air.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study procedures;
  • Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception ; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • Prior allergic reaction to the study drug(s) involved in this protocol;
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
  • Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis or serum pregnancy test within 7 days prior to administration of RAD001)
  • Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
  • Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy etc)
  • Patients who have had a major surgery or significant traumatic injury within 4 weeks of the start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring anesthesia) or patients that may require major surgery during the course of the study.
  • Prior treatment with any investigational drug within the preceding 4 weeks.
  • History of noncompliance to medical regeimens.
  • Patients unwilling to or unable to comply with the protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: BrUOG-H&N-229-RAD001, Cisplatin and Concurrent Radiation for Locally Advanced, Inoperable Head and Neck Cancer: A PHASE I STUDY- Novartis CRAD001CUS134T

The purpose of this study is to determine if RAD001, to a maximum dose of 10 mg/day, can be safely administered with cisplatin, and concurrent radiotherapy, for patients with locally advanced, inoperable, squamous cell carcinoma of the head and neck.

Read the detailed description

To perform a phase I study of RAD001, to a maximum dose of 10 mg/day, with cisplatin, and concurrent radiotherapy, for patients with locally advanced, inoperable, squamous cell carcinoma of the head and neck

Being tested
RAD001(Afinitor)
Keywords
Head and Neck Cancer, Advanced Inoperable Head & Neck Cancer
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RAD001(Afinitor)Drug

    Also called Afinitor

    Rad001 in combination withCisplatin and Concurrent RT

Study groups in NCT01057277
Study groupRoleWhat they receive
RAD001(Afinitor)ExperimentalRadiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47
Receives: Drug: RAD001(Afinitor)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionMay 2011
  4. Study completionJun 2011

Why it stopped: Pharmaceutical co- re aligned their specialties- no longer will fund H\&N ca

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01057277
Sponsor's protocol ID
BrUOG-H&N-229
Status last verified
Feb 2020
First submitted
9 Dec 2009
Last updated
17 Feb 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RAD001(Afinitor) in people with Head and Neck Cancer, run by howard safran at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01057277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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