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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070343 |
Purpose
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 | Intervention |
|---|---|
|
Melanoma (Skin) |
Biological: oblimersen sodium Drug: dacarbazine |
| Study Type: | Interventional |
| Study Design: | Treatment, 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 |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced malignant melanoma
Previously enrolled on GENTA-GM301 protocol
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent anticoagulation therapy
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000331927, UCLA-0307016, GENTA-GM214 |
| Study First Received: | October 3, 2003 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00070343 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma stage III melanoma |
|
Neoplasms by Histologic Type Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Pharmacologic Actions Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |