Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
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|ClinicalTrials.gov Identifier: NCT00070343|
Recruitment Status : Unknown
Verified November 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 7, 2003
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Biological: oblimersen sodium Drug: dacarbazine|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070343
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-6996|
|Principal Investigator:||John A. Glaspy, MD, MPH||Jonsson Comprehensive Cancer Center|