Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016263
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2001-05-06
Brief Title:
Dacarbazine With or Without Oblimersen G3139 in Treating Patients With Advanced Malignant Melanoma
Sponsor:
Genta Incorporated
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Study Of Dacarbazine Versus Dacarbazine Plus G3139 Bcl-2 Antisense Oligonucleotide In Patients With Advanced Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2002-10
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Oblimersen G3139 may help dacarbazine kill more cancer cells by making tumor cells more sensitive to the drug It is not yet known if dacarbazine is more effective with or without oblimersen G3139
PURPOSE Randomized phase III trial to compare the effectiveness of dacarbazine with or without oblimersen G3139 in treating patients who have advanced malignant melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of dacarbazine with or without oblimersen G3139 in treating patients who have advanced malignant melanoma
Detailed Description:
OBJECTIVES
Compare the survival of patients with advanced malignant melanoma treated with dacarbazine with or without oblimersen G3139
Compare the response rate durable response rate and progression-free survival of patients treated with these regimens
Compare the safety of these regimens in this patient population
Compare the performance status body weight and tumor-related symptoms of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to ECOG performance status 0 vs 1 or 2 extent of metastases and lactate dehydrogenase LDH level skin subcutaneous andor lymph node metastases without visceral involvement and normal LDH vs any visceral metastases or elevated LDH and liver metastases yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive dacarbazine IV over 60 minutes on day 1
Arm II Patients receive oblimersen G3139 IV continuously over days 1-6 followed by dacarbazine IV over 60 minutes on day 6
Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or partial or complete response may be eligible for another 8 courses of treatment in an extension protocol
Patients are followed at least every 2 months for up to 2 years after study
PROJECTED ACCRUAL A total of 750 patients 375 per arm will be accrued for this study
Compare the survival of patients with advanced malignant melanoma treated with dacarbazine with or without oblimersen G3139
Compare the response rate durable response rate and progression-free survival of patients treated with these regimens
Compare the safety of these regimens in this patient population
Compare the performance status body weight and tumor-related symptoms of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to ECOG performance status 0 vs 1 or 2 extent of metastases and lactate dehydrogenase LDH level skin subcutaneous andor lymph node metastases without visceral involvement and normal LDH vs any visceral metastases or elevated LDH and liver metastases yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive dacarbazine IV over 60 minutes on day 1
Arm II Patients receive oblimersen G3139 IV continuously over days 1-6 followed by dacarbazine IV over 60 minutes on day 6
Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or partial or complete response may be eligible for another 8 courses of treatment in an extension protocol
Patients are followed at least every 2 months for up to 2 years after study
PROJECTED ACCRUAL A total of 750 patients 375 per arm 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 |
|---|---|---|---|
| GENTA-GM301 | None | None | None |
| UCLA-0207109 | None | None | None |