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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
Not Enrolling
Both
Melanoma

Thank you

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 TexasHouston, Texas  77030-4009
Cancer Care AssociatesTulsa, Oklahoma  74136
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Hematology Oncology Centers of the Northern RockiesBillings, Montana  59101
The West ClinicMemphis, Tennessee  38120
Texas Oncology - Sammons Cancer CenterDallas, Texas  75246
University of South Alabama Hospital, Mitchell Cancer InstituteMobile, 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 AssociatesSioux City, Iowa  51101
Morristown Memorial - Atlantic Healthcare SystemMorristown, New Jersey  07960
Cancer Care Associates, Site 1Tulsa, Oklahoma  74104
St. Luke's Cancer CenterBethlehem, Pennsylvania  18015