NCT00020787

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 8, 2004

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

July 11, 2001

Last Update Submit

July 30, 2020

Conditions

Esophageal CancerGastric Cancer

Keywords

stage IV gastric cancerrecurrent gastric cancerstage IV esophageal cancerrecurrent esophageal canceradenocarcinoma of the stomachadenocarcinoma of the esophagus

Outcome Measures

Primary Outcomes (1)

  • To determine whether a concomitant G17DT-chemotherapy regimen affects tumor response in subjects with gastric or gastroesophageal cancer.

    6 months to 1 year

Secondary Outcomes (1)

  • Time to disease progression, best overall response, and survival will be evaluated in the intent-to-treat population and the evaluable population.

    6 months to 1 year

Study Arms (1)

Treatment

EXPERIMENTAL

See intervention description.

Biological: G17DT ImmunogenDrug: cisplatinDrug: fluorouracil

Interventions

G17DT ImmunogenBIOLOGICAL

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

Treatment
cisplatinDRUG

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.

Also known as: cisplatinum, cis-diamminedichloroplatinum(II)
Treatment
fluorouracilDRUG

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

Also known as: 5-FU
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (2)

  • Ajani JA, Hecht JR, Ho L, Baker J, Oortgiesen M, Eduljee A, Michaeli D. An open-label, multinational, multicenter study of G17DT vaccination combined with cisplatin and 5-fluorouracil in patients with untreated, advanced gastric or gastroesophageal cancer: the GC4 study. Cancer. 2006 May 1;106(9):1908-16. doi: 10.1002/cncr.21814.

    PMID: 16568451RESULT

  • Hecht JR, Ajani JA, Michaeli D: A multicenter phase II study of cisplatin (CDDP) and 5-fluorouracil (5-FU) in combination with G17DT immunogen in patients with locally recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction previously untreated for advanced disease. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1035, 258, 2003.

    RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

gastrin immunogenCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joel R. Hecht, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 8, 2004

Study Start

July 1, 2001

Primary Completion

January 1, 2002

Study Completion

December 1, 2002

Last Updated

August 3, 2020

Record last verified: 2012-07

Locations

US(1)