Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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



- 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.


- 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

- 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.


- 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

- 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.

Inclusion Criteria


- Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC)

- No mixed histology

- Presence of ≥ 1 neuroendocrine marker (synaptophysin, chromogranin, or CD56) in tumor

- Achieved partial response (PR), complete response (CR), or stable disease (SD) ≤ 12
weeks of completing 4-6 courses of platinum-based chemotherapy regimen for
extensive-stage SCLC

- Patients with PR or SD must have measurable disease, defined as ≥ 1 lesion whose
longest diameter can be accurately measured as ≥ 2.0 cm but < 10 cm by chest
x-ray OR as ≥ 1.0 cm but < 10 cm by CT scan, CT component of a PET/CT scan, or

- If CT scan is used, it must be used for both pre- and post-treatment tumor

- Measurable disease is not required for patients with CR

- Brain metastases allowed provided they have been stable for ≥ 4 weeks after
completion of prior radiotherapy


- ECOG performance status 0 or 1

- Life expectancy of ≥ 8 weeks

- ANC ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 9 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal

- AST ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use adequate contraception

- Able to comply with study procedures to minimize virus exposure to others

- Willing to provide required biologic specimens

- Willing to return to NCCTG/CTSU enrolling institution for follow-up

- Adequate lung function (i.e., not oxygen dependent)

- The patient is eligible if not on a 24-hour oxygen schedule

- No second primary malignancy within the past 5 years, except for the following:

- Carcinoma in situ of the cervix

- Non-melanomatous skin cancer

- History of low-grade (Gleason score ≤ 6) localized prostate cancer (even if
diagnosed < 5 years prior to study entry)

- Stage I breast cancer that was treated ≥ 5 years before study entry

- Transitional cell carcinoma of the bladder (in situ)

- No active hepatitis B or hepatitis C

- No clinically significant infection

- No significant traumatic injury within the past 4 weeks

- No concurrent uncontrolled illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situation that would limit compliance with
study requirements


- See Disease Characteristics

- More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to
skeletal metastases)

- Other prior radiation therapy (including WBRT, PCI, or Gamma Knife) is permitted as
long as the following are true:

- Recovered from prior radiotherapy (alopecia allowed)

- No prior consolidation radiation therapy to the chest

- No prior radiotherapy to > 25% of bone marrow

- For patients without brain metastases, WBRT or standard of care PCI completed ≥
2 weeks before administration of NTX- 010/placebo

- More than 365 days since prior immunotherapy or biologic therapy

- More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy

- More than 2 weeks since prior minor surgery*

- No prior exposure to the Seneca Valley virus (NTX-010), as determined by negative
serum antibodies

- No concurrent combination antiretroviral therapy for HIV-positive patients NOTE:
*Insertion of a vascular access device is not considered major or minor surgery.

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Julian Molina, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic



Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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