A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Melanoma
Both
Melanoma
Trial Information
A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
Inclusion Criteria:
- Histologically confirmed diagnosis of melanoma
- Progressive disease that is not surgically resectable, or metastatic Stage IV
- Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal
- No prior chemotherapy
- Measurable disease
- ECOG performance status ≤ 1
- At least 4 weeks and recovery from effects of major prior surgery or other therapy,
including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
- Prior immunotherapy allowed
- Adequate organ function
Exclusion Criteria:
- Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense
treatment
- Primary ocular or mucosal melanoma
- Bone-only metastatic disease
- History or presence of brain metastasis or leptomeningeal disease
- Significant medical disease other than cancer
- Organ allograft
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression-free survival and overall survival
Outcome Time Frame:
Every 42 days from date of randomization during protocol therapy
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
AGENDA
NCT ID:
NCT00518895
Start Date:
July 2007
Completion Date:
May 2011
Related Keywords:
- Melanoma
- Melanoma
- Advanced Melanoma
- Malignant Melanoma
- Metastatic Melanoma
- Skin Cancer
- Genasense
- oblimersen
- antisense
- Bcl-2 antisense
- G3139
- dacarbazine
- Melanoma
Name | Location |
|---|---|
| MD Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
| Hematology Oncology Centers of the Northern Rockies | Billings, Montana 59101 |
| The West Clinic | Memphis, Tennessee 38120 |
| Texas Oncology - Sammons Cancer Center | Dallas, Texas 75246 |
| University of South Alabama Hospital, Mitchell Cancer Institute | Mobile, Alabama 36607 |
| San Diego Pacific Oncology and Hematology Associates Inc. | Encinitas, California 92024 |
| Redwood Regional Medical Group, Inc. | Santa Rosa, California 95403 |
| Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
| Morristown Memorial - Atlantic Healthcare System | Morristown, New Jersey 07960 |
| Cancer Care Associates, Site 1 | Tulsa, Oklahoma 74104 |
| St. Luke's Cancer Center | Bethlehem, Pennsylvania 18015 |
