RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
20 februari 2013 bijgewerkt door: Jochen Lorch, MD, Dana-Farber Cancer Institute
A Phase I Trial Using RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer
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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
- Most patients receiving treatment for head and neck cancer will develop difficulty swallowing food and drinking liquids during the course of therapy. For this reason, it will be recommended that a PEG (percutaneous endoscopic gastrostomy) tube be placed in the participants stomach prior to undergoing the study regimen. This is to help maintain weight and nutritional health.
- Since we are looking for highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates will receive the same dose of RAD001 or cisplatin.
- The study regimen will last for seven weeks. During each week of study participation the following will occur: Radiation will be administered each weekday (5 days per week). Cisplatin will be given intravenously at the start of each week. RAD001 will be given to the participant to take at home. Participants will take the study drug once a day in the morning starting on day 1.
- A history and physical exam will be performed weekly while participant's are receiving radiation treatment. Blood tests for routine laboratory testing will be performed weekly.
- Each month for the first two months after participants finish radiation therapy and stop taking RAD001 and cisplatin, they will have a physical ezam, a neurologic exam, and blood tests. X-rays, a CT, MRI and/or PET scans will also be performed a the two month visit. After the first two months, follow-up will continue every 1-2 months for the first year. Additionally, every 6 months for the first two years, follow-up visits will include an assessment of speech and swallowing functions along with X-rays, CT, MRI and/or PET scans.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
3
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02115
- Dana-Farber Cancer Institute
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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.
- 18 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
Exclusion Criteria:
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Rad001 with cisplatin
|
Administered daily 5 days per week
Andere namen:
Taken orally once a day
Administered intravenously once a week
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
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.
Tijdsspanne: 2 years
|
2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Obtain preliminary results on efficacy of the RAD001, cisplatin and radiation therapy combination in patients with locally advanced HNSCC.
Tijdsspanne: 3 years
|
3 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jochen Lorch, MD, Dana-Farber Cancer Institute
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2010
Primaire voltooiing (Werkelijk)
1 februari 2012
Studieregistratiedata
Eerst ingediend
26 januari 2010
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2010
Eerst geplaatst (Schatting)
28 januari 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
22 februari 2013
Laatste update ingediend die voldeed aan QC-criteria
20 februari 2013
Laatst geverifieerd
1 februari 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 09-342
- CRAD001C4540T (Andere identificatie: Novartis Pharmaceutical)
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