Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation
5. november 2018 oppdatert av: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Evaluation of Immunologic Responses in HPV-Associated Oropharyngeal Carcinoma Patients Receiving Chemoradiation Therapy
The primary purpose of this research is to investigate anti-tumor immune responses in patients undergoing chemotherapy and radiation for Head and Neck Cancers.
Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in changes in the tumor microenvironment. We hypothesize that these changes during daily fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune responses.
Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy in the presence or absence of lymphopenia.
- This study will determine whether specific anti-tumor immune responses (Specific Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation treatment for Head and Neck Cancers.
- This study will evaluate the presence or absence of HPV (human papillomavirus) specific immune responses before, during, and after treatment for Head and Neck Cancers.
- This study will also evaluate whether decreased white blood cell counts may affect development of immune responses in Head and Neck cancer patients undergoing treatment.
Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you are older than 18 years of age, capable of providing informed consent, have a life expectancy of greater than 4 months, and have a good performance status.
You are eligible irregardless of your HPV positive or negative status. People with HPV positive (human papillomavirus associated) head and neck cancer may join. People with HPV negative head and neck cancer may also join.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
As this is a pilot study seeking to describe the potential impact of chemoradiotherapy on the natural history of any immunologic response in HPV-associated OPSCC, the timing of the venipunctures reflect the goal to sample throughout the course of CTRT (chemoradiation therapy)and will permit some variability based on the number of radiation fractions delivered.
It also reflects considerations of time points that lend themselves to both the venipuncture and tumour biopsy based on the toxicity and response profile of the chemoradiation in the HPV-associated OPSCC patient.
As such, 10 subjects with HPV-associated OPSCC and 10 subjects with non-HPV associated HNSCC seen by the respective disciplines of otolaryngology-head and neck surgery, radiation oncology, or medical oncology as clinically indicated will be enrolled on this clinical protocol.
Importantly, clinical therapeutic recommendations, radiation treatment plans, and therapeutic drugs will not be altered by enrollment in this protocol.
Tumors which are directly visible through in office laryngopharyngoscopy and easily accessible (i.e.
oropharyngeal tonsil) will be directly biopsied (non-percutaneously) and analyzed as detailed below.
Studietype
Observasjonsmessig
Registrering (Faktiske)
20
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- The Johns Hopkins SKCCC
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
10 subjects with HPV-associated OPSCC (Oropharyngeal Squamous Cell Carcinoma) and 10 subjects with non-HPV associated HNSCC (Head and Neck Squamous Cell Carcinoma)
Beskrivelse
Inclusion Criteria:
- patients must have head and neck cancer and be receiving concurrent chemotherapy and radiation
- patients greater than or equal to 18 years of age
- patients must be capable of providing informed consent
- patients must have a life expectancy of greater than 4 months
- patients must have an adequate performance status
Exclusion Criteria:
- Patients must not have had surgery for their head and neck cancer
- Patients must not have a diagnosis of an immunosuppressant disease
- Patients must not have certain uncontrolled concurrent illnesses
- Patients must not a history of autoimmune disease
- Patients must not be pregnant, become pregnant or breast feeding
- Patients must not have a history of certain prior malignancies
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Chemoradiation with Research Samples
Standard of care chemoradiation therapy will be given as clinically indicated by the treating physicians.
4 research blood and tissue samples will be obtained.
One before treatment starts, 2 while treatments are being received and finally one after treatments are completed.
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research blood draw and tissue biopsy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Compare Systemic and Local Immunologic Changes During Chemoradiation
Tidsramme: Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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Primary objective: To evaluate the systemic and local immunologic changes which may occur during a standard treatment course of combined chemoradiation for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) and non-HPV associated head and neck squamous cell carcinomas (HNSCC).
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Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Relationship of Radiotherapy-Related Lymphopenia and Changes in Cellular Immunity During Chemoradiation
Tidsramme: Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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Secondary objective: To explore the relationship between radiotherapy-related lymphopenia and changes in cellular immunity during a course of chemoradiation for HPV-associated OPSCC.
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Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Harry Quon, M.D., Johns Hopkins SKCCC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. januar 2015
Primær fullføring (Faktiske)
15. februar 2017
Studiet fullført (Faktiske)
15. mars 2017
Datoer for studieregistrering
Først innsendt
7. oktober 2013
Først innsendt som oppfylte QC-kriteriene
8. oktober 2013
Først lagt ut (Anslag)
9. oktober 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- J13158
- IRB00092006 (Annen identifikator: JHMIRB)
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