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Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer

19. april 2017 opdateret af: Robert I. Haddad, MD, Dana-Farber Cancer Institute

A Multi-Center, Open-Label, Multiple Administration, Rising Dose Study of the Safety, Tolerability, and Efficacy of IL-12 Gene Medicine in Patients With Unresectable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

7

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Females must be non-pregnant and non-lactating and either surgically sterile (via hysterectomy or bilateral tubal ligation), at least one year post-menopausal, or using acceptable methods of contraception for the duration of the study.
  • Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study.
  • Disease: biopsy-proven unresectable or recurrent/refractory squamoussell_eareinoma_of_the:head-and-neck-(usualLy -Stage-Di-or-IV) -
  • Tumor accessible to direct injection
  • Karnofsky performance of at least 70%
  • Life expectancy of at least three months
  • Able to give written informed consent

Exclusion Criteria:

  • Infection (concurrent or within previous 2 weeks)
  • Active or clinically-relevant viral illnesses.
  • Use of corticosteroids, high-dose non-steroidal antiinflammatory, or immunosuppressive drugs
  • Chemotherapy, radiotherapy or immunotherapy within 28 days of study entry or during the course of study
  • Respiratory disease sufficient to influence oxygenation of arterial blood
  • Active liver disease with transaminases >3 times the upper limit of normal
  • Previous history of liver disease
  • NYHA Class EU or greater heart failure
  • Serum creatinine of greater than 1.5 times the upper limit of normal
  • Polymorphonuclear neutrophilic leukocyte count <3,000/mm3
  • Platelet count <50,000/mm 3
  • Tumor involving major blood vessels or obstructing the airway
  • Previous treatment with viral-based gene therapy, recombinant DNA products, or bacterial plasmids
  • Use of an investigational drug within 30 days of screening
  • Other malignancies requiring treatment during the study
  • Scheduled surgical resection
  • History of autoimmune disease, including rheumatic disease, Crohn's disease, etc. ,
  • Known allergy to polyvinylpyrrofidone (PVP) or related products
  • History of psychiatric disabilities or seizures.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IL-12 Injection 3mg/ml [Phase I]
The dosing schedule will consist of eight injections 3 mg/ml of formulated plasmid over a seven week period.
Biologisk: IL-12
Andre navne:
  • NFSK
  • CLMF
  • P35
  • Interleukin-12-gen
Eksperimentel: IL-12 Injection 6mg/ml [Phase I]
The dosing schedule will consist of eight injections 6mg/ml of formulated plasmid over a seven week period.
Biologisk: IL-12
Andre navne:
  • NFSK
  • CLMF
  • P35
  • Interleukin-12-gen
Eksperimentel: IL-12 Injection MTD [Phase II]
The dosing schedule will consist of eight injections over a seven week period of formulated plasmid at the MTD established in the phase I portion.
Biologisk: IL-12
Andre navne:
  • NFSK
  • CLMF
  • P35
  • Interleukin-12-gen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Tolerated Dose (MTD) [Phase I]
Tidsramme: Assessed during therapy up to 7 weeks.
The MTD of IL-12 gene medicine is determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed in the two dose levels planned then evaluation of a third escalation will be considered. If the MTD is not reached, the dose selected for use in the phase II portion will be defined as the maximum volume that can be reasonably and safely injected into the tumor.
Assessed during therapy up to 7 weeks.
Dose Limiting Toxicity (DLT) [Phase I]
Tidsramme: Assessed during therapy up to 7 weeks.
A DLT was defined as grade 4 hematologic toxicity greater than 5 days duration or grade 3 or higher non-hematologic toxicity based on NCI common toxicity criteria (CTCAEv2).
Assessed during therapy up to 7 weeks.
Grade 3-4 Toxicity Rate [Phase II]
Tidsramme: Assessed until last scheduled on-study visit up to visit 12/day 112.
All Grade 3-4 events based on CTCAEv2 as reported on case report forms.
Assessed until last scheduled on-study visit up to visit 12/day 112.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Progressive Disease (TTP) [Phase III]
Tidsramme: Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.

Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD).

Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD).
Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.
Response [Phase II]
Tidsramme: Measurement by CT occurs up to visit 12/day 112.
Best response on treatment classifies patients into 4 groups: complete response (CR) is complete disappearance of all signs, symptoms, biochemical and radiographic evidence of tumor for a minimum of 1 month; partial response (PR) is >/=50% decreases in tumor area for at least 4 weeks without an increase in size of other lesions of >25% or appearance of new lesions; progressive disease (PD) is >50% increase in size of any lesion present at baseline or after response, or appearance of a new lesion; and stable disease (SD) is neither PR or better nor PD.
Measurement by CT occurs up to visit 12/day 112.
Overall Survival (OS) [Phase II]
Tidsramme: Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.
OS is defined as the duration of time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
Measurement by CT occurs up to the earliest of progression, death or 4 months after enrollment of last patient.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dana-Farber Cancer Institute

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: A. Dimitrios Colevas, MD, NCI-Investigational Drug Branch

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 1999

Primær færdiggørelse (Faktiske)

1. november 2000

Studieafslutning (Faktiske)

1. december 2000

Datoer for studieregistrering

Først indsendt

10. december 1999

Først indsendt, der opfyldte QC-kriterier

3. juni 2004

Først opslået (Skøn)

4. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 99-081
  • P30CA006516 (U.S. NIH-bevilling/kontrakt)
  • VALENTIS-DFCI-99081
  • NCI-G99-1578
  • CDR0000067274 (Anden identifikator: Other)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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