Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020787
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2001-07-11
Brief Title:
Vaccine Therapy Plus Chemotherapy in Treating Patients With Metastatic or Locally Recurrent Stomach Cancer or Esophageal Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-GC4C | None | None | None |
| UCLA-0006040 | None | None | None |
| APHTON-BB-IND-8737 | None | None | None |
| NCI-G01-1959 | None | None | None |