Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034554
Status:
COMPLETED
Last Update Posted:
2010-04-09
First Post:
2002-04-30
Brief Title:
Study of gp75 Vaccine in Patients With Stage III and IV Melanoma
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Phase I Study of gp75 DNA Vaccine in Patients With AJCC Stage III and IV Melanoma
Status:
COMPLETED
Status Verified Date:
2009-12
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:
Up to 24 patients with stage III or stage IV melanoma will be enrolled Patients who are currently disease-free but at high risk for relapse are also eligible Patients will receive vaccinations of gp75 at assigned dose levels Patients who exhibit serologic and stableclinical response are eligible to receive booster vaccinations Patients will be evaluated for safety and efficacy throughout the duration of the study In this study the optimal biologically effective dose is defined as the lowest dose of gp75 that results in the production of anti-gp75 antibodies
Detailed Description:
This study is designed to evaluate the safety and feasibility of intramuscular vaccination with gp75 DNA in patients with stage III or IV melanoma Secondary objectives are to observe the patient for any evidence of anti-tumor response and to establish the optimal biologically effective dose Up to 24 evaluable patients with stage III or IV metastatic melanoma or with stage III melanoma currently disease-free but at high risk for recurrence will be enrolled Patients will be be enrolled into an assigned dose group and will receive five vaccinations of gp75 In order for dose escalation to proceed only one patient in the current dose group may have demonstrated a dose limiting toxicity DLT If a second patient experiences such toxicity then both patients will move down to the previous dose level and the previous dose level will be considered to be the MTD If no DLTs are encountered patients will continue on study at the assigned dose level Any patient experiencing a DLT will not receive further vaccination until the toxicity has resolved Patients exhibiting both serological and stableclinical response after receiving the fifth vaccination will be eligible to receive booster vaccinations An additional patient will be accrued to the dose level for every patient that progresses prior to the fifth vaccination
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