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Vaccine Therapy in Treating Patients With Stage IV Melanoma

11. mai 2011 oppdatert av: Mannkind Corporation

A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Studieoversikt

Detaljert beskrivelse

OBJECTIVES:

  • Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine the immunological response, as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment, in patients treated with this drug.
  • Determine the clinical response, as measured by lactic dehydrogenase levels and radiologic assessment of lesions, in patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity. Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment.

Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 10 days after the last dose of study drug.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

Studietype

Intervensjonell

Registrering (Faktiske)

19

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Arizona
      • Tucson, Arizona, Forente stater, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • California
      • Los Angeles, California, Forente stater, 90089
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Cancer Research Center at Boston Medical Center
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Cancer Center
    • Oregon
      • Portland, Oregon, Forente stater, 97213-2967
        • Earle A. Chiles Research Institute at Providence Portland Medical Center

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV melanoma
  • Must have tumor tissue available for determining antigen expression

    • At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry
  • HLA-A2 positive
  • No brain metastases unless completely resected or without evidence of disease after treatment

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • WBC at least 3,000/mm3
  • Platelet count at least 75,000/mm3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Bilirubin no greater than 1.5 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal:

  • Creatinine no greater than 1.5 times ULN
  • Urea no greater than 2.6 times ULN

Other:

  • Not pregnant, nursing, or planning to become pregnant within 6 months of treatment completion
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No medical, sociological, or psychological impediments that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • At least 4 weeks since prior immunomodulatory drugs
  • No other concurrent immunotherapy
  • No concurrent immunomodulatory drugs

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids
  • No concurrent systemic corticosteroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • At least 4 weeks since prior investigational drugs
  • No other concurrent investigational drugs

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1
The first cohort of 6 patients received 500 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
Eksperimentell: Cohort 2
The second cohort of 6 patients received 1000 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
Eksperimentell: Cohort 3
The third cohort of 6 patients received 1500 ug of Synchrovax SEM plasmid DNA vaccine. The maximum tolerated dose (MTD) was to be determined by the observation of DLT at each dose group.
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug

Hva måler studien?

Primære resultatmål

Resultatmål
The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.

Sekundære resultatmål

Resultatmål
The secondary objective of the study was to determine the immunological response of patients as measured by tetramer assay and to assess clinical response by LDH levels and radiological assessment of lesions.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Chief Scientific Officer, Mannkind Corporation

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

1. januar 2002

Primær fullføring (Faktiske)

1. mars 2003

Studiet fullført (Faktiske)

1. april 2003

Datoer for studieregistrering

Først innsendt

9. april 2002

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. mai 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2011

Sist bekreftet

1. mai 2011

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Melanom (hud)

Kliniske studier på MKC1106-MT

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