A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

Part of paid clinical trials in Rogers, Arkansas.

Sponsor
Heat Biologics
Study ID
NCT02117024
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Viagenpumatucel-L — DRUG
    Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
  • Metronomic Cyclophosphamide — DRUG
    One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
  • Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) — DRUG
    Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: * Vinorelbine * Erlotinib * Gemcitabine * Paclitaxel * Docetaxel * Pemetrexed

Study Details

Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.

Key Dates

Start date
Jul 31, 2014
Status verified
Jan 2020
Primary completion
Dec 31, 2017
Completion
Apr 30, 2018

Study Design

Enrollment
66 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Viagenpumatucel-L Plus Metronomic Cyclophosphamide
    Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.
  • Active Comparator: Chemotherapy Alone
    Patients will be treated with a physician's choice regimen until progression.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 3 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupRogersArkansas72758-
University of California San DiegoLa JollaCalifornia92093-
University of California at Los AngelesLos AngelesCalifornia90029-
University of California DavisSacramentoCalifornia95817-
Georgia Regents UniversityAugustaGeorgia30912-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
University of MassachusettsWorcesterMassachusetts01655-
Washington University School of MedicineSt LouisMissouri63110-
SUNY SyracuseSyracuseNew York13210-
Gabrail Cancer CenterCantonOhio44718-
Providence Portland Medical Center- Providence Lung Cancer ClinicPortlandOregon97213-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Texas Oncology PA Texas Cancer CenterAbileneTexas79606-
Mary Crowley Cancer CenterDallasTexas75201-
Cancer Care NorthwestSpokaneWashington99216-
Aurora Research InstituteGreen BayWisconsin54311-

Find similar trials in Rogers, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group· Rogers, ARUniversity of California San Diego· La Jolla, CAUniversity of California at Los Angeles· Los Angeles, CAUniversity of California Davis· Sacramento, CAGeorgia Regents University· Augusta, GAUniversity of Maryland Greenebaum Cancer Center· Baltimore, MD

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