CompletedPhase 3

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

United States8 participantsStarted 2001-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 immunotherap…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months to 1 year

Trial details

NCT IDNCT00020787

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2002-01

View on ClinicalTrials.gov More Esophageal Cancer trials