Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070343
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2003-10-03
Brief Title:
Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Continuation Protocol For G3139 Bcl-2 Antisense Oligonucleotide And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301
Status:
UNKNOWN
Status Verified Date:
2004-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy such as dacarbazine use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may help dacarbazine kill more tumor cells by making them more sensitive to the drug
PURPOSE This clinical trial is studying how well giving oblimersen together with dacarbazine works in treating patients with advanced malignant melanoma that previously responded to treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301
PURPOSE This clinical trial is studying how well giving oblimersen together with dacarbazine works in treating patients with advanced malignant melanoma that previously responded to treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301
Detailed Description:
OBJECTIVES
Primary
Provide continuation therapy with oblimersen G3139 and dacarbazine to patients with advanced malignant melanoma who obtained response or stabilization of disease after prior treatment with this therapy on GENTA-GM301
Secondary
Determine serious adverse events in patients treated with this regimen
OUTLINE This is a nonrandomized open-label multicenter continuation study
Patients receive oblimersen G3139 IV continuously on days 1-5 and dacarbazine IV over 1 hour on day 5 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients who complete 8 courses of treatment may receive additional courses at the discretion of the physician
Patients are followed every 2 months for up to 2 years after initiation of GENTA-GM301 protocol
PROJECTED ACCRUAL A total of 375 patients will be accrued for this study
Primary
Provide continuation therapy with oblimersen G3139 and dacarbazine to patients with advanced malignant melanoma who obtained response or stabilization of disease after prior treatment with this therapy on GENTA-GM301
Secondary
Determine serious adverse events in patients treated with this regimen
OUTLINE This is a nonrandomized open-label multicenter continuation study
Patients receive oblimersen G3139 IV continuously on days 1-5 and dacarbazine IV over 1 hour on day 5 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients who complete 8 courses of treatment may receive additional courses at the discretion of the physician
Patients are followed every 2 months for up to 2 years after initiation of GENTA-GM301 protocol
PROJECTED ACCRUAL A total of 375 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0307016 | None | None | None |
| GENTA-GM214 | None | None | None |