Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Vaccine Therapy Plus Chemotherapy in Treating Patients With Metastatic or Locally Recurrent Stomach Cancer or Esophageal Cancer

30 juli 2020 uppdaterad av: Jonsson Comprehensive Cancer Center

An Open Label, Sequential Multi-Center Multi Dose Study Of G17T Immunogen In Combination With Cisplatin (CDDP) And 5-Fluorouracil (5-FU) In Subjects With Metastatic Or Locally Recurrent Gastric Or Gastroesophageal Cancer Previously Untreated With Chemotherapy For Advanced Disease (Stage IV)

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and chemotherapy in treating patients who have metastatic or locally recurrent stomach cancer or esophageal cancer.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES: I. Determine a safe and immunogenic combination of G17DT with cisplatin and fluorouracil in patients with chemotherapy-naive metastatic or locally recurrent gastric or gastroesophageal cancer. II. Determine the safety profile and tolerability of this regimen in these patients. III. Determine the tumor response rate, disease stabilization, best overall response, time to progression, time to treatment failure, and overall survival in patients treated with this regimen. IV. Determine the correlation of immunological response with clinical efficacy and benefit in patients treated with this regimen. V. Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to one of four treatment regimens. Regimen A: Patients receive high-dose G17DT intramuscularly (IM) on days 7, 35, and 63. Patients also receive cisplatin IV over 1-3 hours on day 1 followed by fluorouracil IV continuously over days 1-5 every 4 weeks in the absence of disease progression or unacceptable toxicity. If inadequate immune response is seen on Regimen A, subsequent patients are treated on Regimen B. If unacceptable toxicity is seen on Regimen A, subsequent patients are treated on Regimen C. If inadequate immune response and unacceptable toxicity are seen on Regimen A, or if unacceptable toxicity is seen on Regimen B or inadequate immune response is seen on Regimen C, then subsequent patients are treated on Regimen D. Regimen B: Patients receive high-dose G17DT IM on days 1, 28, and 56. Patients also receive cisplatin IV over 1-3 hours on day 35 followed by fluorouracil IV continuously over days 35-39 every four weeks in the absence of disease progression or unacceptable toxicity. Regimen C: Patients receive low-dose G17DT IM on days 7, 35, and 63 with chemotherapy as in regimen A. Regimen D: Patients receive low-dose G17DT IM on days 1, 28, and 56 with chemotherapy as in regimen B. Quality of life is assessed at baseline, on day 7, every 2 weeks for 10 weeks, and then every 4 weeks thereafter.

PROJECTED ACCRUAL: A total of 15-75 patients will be accrued for this study within 5-30 months.

Studietyp

Interventionell

Inskrivning (Faktisk)

8

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Signed informed consent.
  • Gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction, histologically proven.
  • Measureable metastatic disease.
  • Male or female subjects, age 18 years and older.
  • Karnofsky performance status score equal to or greater than 70.
  • Life expectancy of at least 3 months.
  • Subjects must be chemotherapy naïve.
  • At least 6 weeks from prior curative radiotherapy and 3 weeks from surgery.
  • Adequate hematological and coagulation parameters: hemoglobin>9.5 g/dL; white blood cell count>3x10^9/L, platelets> 100x10^9/L; international normalized ratio of prothrombin time <1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits.
  • Adequate clinical chemistry parameters: creatinine<1.5mg/dL; total bilirubin<1.5mg/dL; and aspartate aminotransferase and alanine aminotransferase <2.5x upper normal levels.
  • Able to comply with scheduled follow-up and with management of toxicity.
  • Use contraceptive measures, if sexually active

Exclusion Criteria:

  • Previous or current malignancies other than gastric adenocarcinoma, with the exception of adequately treated in situ carcinoma of the cervix, uteri, or nonmelanoma skin cancer
  • Female subjects who are pregnant or nursing
  • Female subjects with reproductive potential refusing a pregnancy test
  • Any previous palliative chemotherapy, adjuvant or neoadjuvant chemotherapy, or investigational drug
  • Any prior anticancer immunotherapy
  • Immunodeficiency
  • Bone marrow transplantation within 1 year
  • Symptomatic peripheral neuropathy > Grade 2 NCI-CTC, Version 2.0 criteria
  • Severe hearing disorder > Grade 2 NCI-CTC, Version 2.0 criteria
  • Known dihydropyrimidine dehydrogenase deficiency
  • Any other sever condition as defined by the following: unstable cardiac disease despite treatment; myocardial infarction within 6 months before study entry; history of significant neurologic or psychiatric disorders including dementia or seizures; active uncontrolled infection; active disseminated intravascular coagulation; or any other serious underlying medical conditions that could impair the ability of the subject to participate in the study
  • Subjects who have previously demonstrated hypersensitivity to diphtheria toxoid
  • Subjects who require chronic administration of corticosteroids
  • Use in the past 30 days or concomitant use of immunosuppressants
  • Use in the past 14 days or chronic concomitant use of proton pump inhibitors
  • Subjects who have a history of hypercalcemia
  • Subjects who cannot be regularly followed up for psychological, social, familial, or geographic reasons
  • Subjects with expected noncompliance to toxicity management

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment
See intervention description.
Biologisk: G17DT Immunogen
Dose: 500 micrograms in 0.2mL Route: Deep intramuscular Schedule: Days 8, 36, and 64; an additional dose at week 2, cycle 7 will be administered
Läkemedel: cisplatin
dose: 100 mg/m2 Route: i.v. infusion in 500 mL in 0.9% NaCl administered up to 3 hours Schedule: day 1, and then every 4 weeks.
Andra namn:
  • cisplatina
  • cis-diamindiklorplatina(II)
Läkemedel: fluorouracil
Dose: 1000mg/m2/day Route: 24-hour continuous infusion in 0.9% NaCl over 5 days Schedule: Day 1 to Day 5 (5-day infusion) and then every 4 weeks
Andra namn:
  • 5-FU

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
To determine whether a concomitant G17DT-chemotherapy regimen affects tumor response in subjects with gastric or gastroesophageal cancer.
Tidsram: 6 months to 1 year
6 months to 1 year

Sekundära resultatmått

Resultatmått
Tidsram
Time to disease progression, best overall response, and survival will be evaluated in the intent-to-treat population and the evaluable population.
Tidsram: 6 months to 1 year
6 months to 1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Jonsson Comprehensive Cancer Center

Utredare

  • Studiestol: Joel R. Hecht, MD, Jonsson Comprehensive Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2001

Primärt slutförande (Faktisk)

1 januari 2002

Avslutad studie (Faktisk)

1 december 2002

Studieregistreringsdatum

Först inskickad

11 juli 2001

Först inskickad som uppfyllde QC-kriterierna

7 januari 2004

Första postat (Uppskatta)

8 januari 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 augusti 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juli 2020

Senast verifierad

1 juli 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CDR0000068713
  • UCLA-0006040
  • APHTON-BB-IND-8737
  • NCI-G01-1959
  • UCLA-GC4C

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Magcancer

Kliniska prövningar på G17DT Immunogen

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Slovenia

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera