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A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease


Inclusion Criteria:



- Males or females age ≥ 18 years

- Stage IIIb, IIIc or stage IV disease that is not surgically resectable

- Injectable disease (i.e. suitable for direct injection or through the use of
ultrasound guidance)

- at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion >10 mm in
longest diameter or, multiple injectable melanoma lesions which in aggregate have a
longest diameter of >10 mm

- Serum LDH levels less than 1.5 x ULN

- ECOG Performance Status of 0 or 1

- Prolongation in INR, PT, and PTT when the result is from therapeutic anticoagulation
treatment are permitted for patients whose injectable lesions are cutaneous and/or
subcutaneous such that direct pressure could be applied in the event of excessive
bleeding

Exclusion Criteria:

- Clinically active cerebral or any bone metastases. Patients with up to 3
(neurological performance status of 0) cerebral metastases may be enrolled, provided
that all lesions have been adequately treated with stereotactic radiation therapy,
craniotomy, gammaknife therapy, with no evidence of progression, and have not
required steroids, for at least two (2) months prior to randomization

- Greater than 3 visceral metastases (this does not include lung metastases or nodal
metastases associated with visceral organs). For patients with <3 visceral
metastases, no lesion >3 cm, and liver lesions must meet RECIST criteria for SD for
at least 1 month prior to randomization

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Achieving a statistically significant improvement in durable response rate, defined as the rate of CR or PR lasting continuously for 6 or more months, as compared to control therapy.

Outcome Time Frame:

Every 12 weeks

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

005/05

NCT ID:

NCT00769704

Start Date:

April 2009

Completion Date:

September 2014

Related Keywords:

  • Melanoma
  • Melanoma
  • OncoVEXGM-CSF
  • GM-CSF
  • Stage IIIb, IIIc and IV Disease
  • oncolytic
  • OncoVex
  • TVec
  • talimogene laherparepvec
  • Melanoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
University of Colorado Cancer CenterDenver, Colorado  80262
Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Mount Sinai School of MedicineNew York, New York  10029
Rhode Island HospitalProvidence, Rhode Island  02903
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Huntsman Cancer InstituteSalt Lake City, Utah  84112
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Rush University Medical CenterChicago, Illinois  60612-3824
John Wayne Cancer InstituteSanta Monica, California  90404
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Mary Crowley Medical Research CenterDallas, Texas  75246
Duke University Medical CenterDurham, North Carolina  27710
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Emory UniversityAtlanta, Georgia  30322
UCLA Medical CenterLos Angeles, California  90095-7059
Lakeland Regional Cancer CenterLakeland, Florida  33805
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Gabrail Cancer CenterCanton, Ohio  44718
Vanderbilt Ingram Cancer CenterNashville, Tennessee  37232
University of MiamiMiami, Florida  33136
Kansas City Cancer CenterKansas City, Missouri  64111
Indiana UniversityIndianapolis, Indiana  46202
University of Arizona Cancer CenterTucson, Arizona  85724
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Mountainside HospitalMontclair, New Jersey  07042
Baptist Cancer InstituteJacksonville, Florida  32207
Cleveland Clinic Foundation, Taussig Cancer CenterCleveland, Ohio  44195
Hubert H Humphrey Cancer CenterRobbinsdale, Minnesota  55422
Investigative Clinical Research of IndianaIndianapolis, Indiana  46254
New Mexico Cancer Care AllianceAlbuquerque, New Mexico  87106
San Francisco Oncology AssociatesSan Francisco, California  94115
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Intermountain Medical CenterMurray, Utah  84157
University of Iowa Hospitals & ClinicsIowa City, Iowa  52242
St Luke's Hospital & Health NetworkBethlehem, Pennsylvania  18015
St. Louis University HospitalSt. Louis, Missouri  63110
University of California San Diego, Moores Cancer CenterLa Jolla, California  92093
Northern California Melanoma Center, St. Mary's Medical CenterSan Francisco, California  94117
Redwood Regional Medical Group Inc, North Bay Melanoma ProgramSebastopol, California  95472
Cancer Care Center at Lutheran General HospitalPark Ridge, Illinois  60068
Columbia Medical UniversityNew York, New York  10032
University of North Carolina At Chapel Hill School of MedicineChapel Hill, North Carolina  27599
Earle A Chiles Research Institute, Providence Cancer CenterPortland, Oregon  97213
Institute for Translational Oncology ResearchGreenville, South Carolina  29605
Texas Cancer Center, AbileneAbilene, Texas  79701
University of Texas - MD AndersonHouston, Texas  77030
Texas Oncology, Allison Cancer CenterMidland, Texas  79701
Aurora/St. Luke's Medical CenterMilwaukee, Wisconsin  53215