Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395070
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2006-10-31
Brief Title:
A Phase 3 Pivotal Trial Comparing Allovectin-7 Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
Sponsor:
Vical
Organization:
Vical
Study Overview
Official Title:
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7 Compared to Dacarbazine DTIC or Temozolomide TMZ in Subjects With Recurrent Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2013-09
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:
To compare the safety and efficacy of Allovectin-7 versus Dacarbazine DTICor Temozolomide TMZ in subjects with recurrent stage 3 or stage 4 melanoma
Detailed Description:
Eligible patients will have a 66 chance of receiving Allovectin-7 alone an investigational product designed to train your bodys immune system to recognize and destroy tumor cells vs a 33 chance of receiving standard chemotherapy either dacarbazine or temozolomide The treatment course recommended for patients who receive Allovectin-7 is a minimum of 16 weeks Each cycle will consist of weekly injections of Allovectin-7 alone for six weeks followed by two weeks of observation and assessments For patients who receive the chemotherapy alone their treatment course will follow standard dosing During the trial all patients tumors will be closely monitored Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years
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