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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
N/A
Open (Enrolling)
Both
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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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
tissue

- 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
MRI

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

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Julian Molina, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

Unspecified

Study ID:

CDR0000659547

NCT ID:

NCT01017601

Start Date:

January 2010

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
MeritCare BemidjiBemidji, Minnesota  56601
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - NorthwestTacoma, Washington  98405-0986
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Wood County Oncology CenterBowling Green, Ohio  43402
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Highland General HospitalOakland, California  94602
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Hematology Oncology CenterElyria, Ohio  44035
Community Cancer CenterElyria, Ohio  44035
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Providence Centralia HospitalCentralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Rocky Mountain OncologyCasper, Wyoming  82609
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rockwood Clinic Cancer Treatment CenterSpokane, Washington  99204-2967
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
El Camino Hospital Cancer CenterMountain View, California  94040
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
York Hospital's Oncology Treatment CenterYork, Maine  03909
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Erlanger Cancer Center at Erlanger Hospital - BaronessChattanooga, Tennessee  37403
New Ulm Medical CenterNew Ulm, Minnesota  56073
Roger Maris Cancer Center at MeritCare HospitalFargo, North Dakota  58122
St. Nicholas HospitalSheboygan, Wisconsin  53081
Overlake Cancer Center at Overlake Hospital Medical CenterBellevue, Washington  98004
Providence Regional Cancer PartnershipEverett, Washington  98201
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
St. Joseph Regional Medical CenterLewiston, Idaho  83501
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700
Epic Care - OaklandOakland, California  94612
Benefis Sletten Cancer InstituteGreat Falls, Montana  59405