A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
OBJECTIVES:
Primary
- To compare the progression-free survival (PFS) of patients with extensive-stage small
cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo.
Secondary
- To compare the overall survival (OS) of patients treated with NTX-010 vs placebo.
- To describe the adverse events profile and safety of NTX-010 in this patient
population.
- To determine the antitumor response rate, as assessed by RECIST criteria, and duration
of tumor response in this patient population.
- To assess the quality of life of this patient population.
Exploratory
- To determine the relationship between the presence of neutralizing antibodies and PFS.
- To assess whether or not a slow viral clearance is associated with better response as
determined by PFS.
- To determine any potential impact of the presence of one or several neuroendocrine
markers in the tumor sample (synaptophysin, chromogranin, or CD56) on PFS and OS.
- To determine any potential relationship between presence of cell surface determinants
of NTX-010 tropism in the tumor tissue and clinical outcomes such as improved PFS and
OS.
- To determine any potential relationship between the loss of integrity of IFN signaling
in the tumor tissue and clinical outcomes such as improved PFS and OS.
- To assess whether or not the presence of circulating tumor cells permissive to NTX-010
is associated with better clinical outcomes as determined by PFS and OS.
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0 vs 1), tumor response to standard chemotherapy (partial response vs stable disease
vs complete response), and time between completion of chemotherapy to randomization 1 month
(≤1 month) vs 2 months (>1 month but ≤ 2 months) vs 3 months (> 2 months but ≤ 3 months).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1
hour on day 1.
- Arm II: Patients receive a single dose of placebo IV over 1 hour on day 1. In both
arms, patients may also undergo prophylactic cranial irradiation (PCI) daily on days
22-35 if they have not previously undergone PCI or whole-brain radiotherapy.
Quality of life is assessed at baseline and then periodically during the study.
Blood samples are collected periodically for viral clearance and antiviral neutralizing
antibody levels, circulating tumor cells, and other biomarker laboratory studies.
After completion of study therapy, patients are followed up periodically for up to 5 years.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Progression-free survival
No
Julian Molina, MD, PhD
Principal Investigator
Mayo Clinic
Unspecified
CDR0000659547
NCT01017601
January 2010
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
MeritCare Broadway | Fargo, North Dakota 58122 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Highland General Hospital | Oakland, California 94602 |
Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Hematology Oncology Center | Elyria, Ohio 44035 |
Community Cancer Center | Elyria, Ohio 44035 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Rockwood Clinic Cancer Treatment Center | Spokane, Washington 99204-2967 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
York Hospital's Oncology Treatment Center | York, Maine 03909 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
Valley Medical Oncology Consultants - Castro Valley | Castro Valley, California 94546 |
Valley Medical Oncology | Fremont, California 94538 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
Erlanger Cancer Center at Erlanger Hospital - Baroness | Chattanooga, Tennessee 37403 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
St. Nicholas Hospital | Sheboygan, Wisconsin 53081 |
Overlake Cancer Center at Overlake Hospital Medical Center | Bellevue, Washington 98004 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Cancer Center of Kansas, PA - McPherson | McPherson, Kansas 67460 |
St. Joseph Regional Medical Center | Lewiston, Idaho 83501 |
Mercy Cancer Center - West Lakes | Clive, Iowa 50325 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
Epic Care - Oakland | Oakland, California 94612 |
Benefis Sletten Cancer Institute | Great Falls, Montana 59405 |