Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy (STOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by NovaRx Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NovaRx Corporation
ClinicalTrials.gov Identifier:
NCT00676507
First received: May 8, 2008
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer.

Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Neoplasm
Carcinoma Non-small Cell Lung Cancer Stage IIIA
Carcinoma Non-small Cell Lung Cancer Stage IIIB
Carcinoma Non-small Cell Lung Cancer Stage IV
Biological: Lucanix™
Other: Placebo Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy

Resource links provided by NLM:


Further study details as provided by NovaRx Corporation:

Primary Outcome Measures:
  • Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the Best Support Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the response duration in subjects treated with Lucanix™ compared to the Best Supportive Care control group. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the Best Supportive Care control group. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • Adverse events of subjects treated with Lucanix™ will be compared to subjects in the Best Supportive Care control group. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 506
Study Start Date: July 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment Arm: This course of therapy is Best Support Care (BSC) plus monthly intradermal (ID) injections of Lucanix™ (belagenpumatucel-L) consisting of 25,000,000 cells in a volume of 0.40 mL.
Biological: Lucanix™
Treatment Arm: Subjects receive Lucanix™ (belagenpumatucel-L) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
Other Name: belagenpumatucel-L
Placebo Comparator: Control Arm
Control Arm: This course of therapy is Best Support Care (BSC) plus a placebo injection that consists of 0.15% Intralipid® in solution composed of the cryopreservation formulation minus the gene modified cells and dimethyl sulfoxide (DMSO) in a volume of 0.40 mL.
Other: Placebo Comparator
Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
Other Name: Placebo Comparator

Detailed Description:

Primary Efficacy Endpoints:

  • Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.

Secondary Efficacy Endpoints:

  • Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the BSC control group.
  • Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS) compared to treatment within the BSC control group.
  • Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the BSC control group.
  • Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the BSC control group.
  • Evaluate the response duration in subjects treated with Lucanix™ compared to the BSC control group.
  • Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the BSC control group.
  • Adverse events of subjects treated with Lucanix™ will be compared to subjects in the control group.

Outline: This is a multicenter study. Subjects are stratified according to disease stage (IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable disease vs partial response or complete response), prior treatment with front-line chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in combination with another anticancer agent). Subjects are randomized to 1 of 2 treatment arms.

  • Treatment Arm: Subjects receive belagenpumatucel-L (Lucanix™) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
  • Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.

Blood samples are collected and analyzed for routine chemistry, cytokines, chemokines, and some instances circulating tumor cells, including response to multiple lung cancer-associated antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung tumor-associated antigens by in vitro proliferation assays; regulatory T-cell (Treg) phenotype by flow cytometry; and Treg function.

Subjects complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline, on the days of treatment, 30 days after completion of study treatment, and then every 3 months for 1 year.

After completion of study treatment, subjects are followed every 3 months for 1 year and then annually for 4 years.

In two phase II trials, many subjects who received Lucanix™ at the same dose that will be administered in this trial had long-term disease stability with a good quality of life.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
  • Stage IIIA (T3N2 only) or
  • Stage IIIB or
  • Stage IV.
  • Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
  • Not less than four weeks nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
  • Subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
  • Signed informed consent.
  • Not less than 18 years and not more than 75 years old.
  • Estimated life expectancy of at least 12 weeks.
  • Performance status (ECOG) ≤ 2.
  • Absolute neutrophil count ≥ 1,500/mm3.
  • Hemoglobin ≥ 9 g/dL.
  • Platelet count ≥ 100,000/mm3.
  • Albumin levels ≥ 2.5 g/dL.
  • Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
  • Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
  • Creatinine ≤ 1.5 × ULN.
  • Alkaline phosphatase ≤ 5 × ULN.

Exclusion Criteria:

  • Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
  • Prior splenectomy.
  • Any surgery involving general anesthesia < 4 weeks prior to study registration.
  • Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
  • Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
  • Subjects with documented active brain metastasis(es) at the time of study entry are ineligible. However, subjects treated for brain metastasis(es) are eligible if they have been stable for ≥ 2 months.
  • Painful bone metastases, or bone metastases that require immediate therapy.
  • Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
  • Known allergies to eggs or soy.
  • Significant weight loss (≥ 10% body weight in preceding 6 weeks).
  • Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
  • Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
  • NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
  • Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
  • History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
  • Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
  • Known active Epstein-Barr infection within ≤ 60 days of study registration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676507

  Hide Study Locations
Locations
United States, Alabama
Southern Cancer Center
Mobile, Alabama, United States, 36608
United States, Alaska
Alaska Regional Hospital
Anchorage, Alaska, United States, 99508
United States, Arizona
Mayo Clinic Cancer Center
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Clopton Clinic Hematology/Oncology
Jonesboro, Arkansas, United States, 72401
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
University of California, San Diego
La Jolla, California, United States, 92093
UCLA Pasadena Oncology
Pasadena, California, United States, 91105
Cancer Care Associates
Redondo, California, United States, 90277
Innovative Research Center of California
San Diego, California, United States, 92103
Sansum Clinic
Santa Barbara, California, United States, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
UCLA Cancer Center
Santa Monica, California, United States, 90404
UCLA Cancer Center-Valencia
Valencia, California, United States, 91355
UCLA Cancer Center
Westlake Village, California, United States, 91361
United States, Colorado
University of Colorado Health Science Center
Aurora, Colorado, United States, 80045
United States, Florida
Pasco Hernando Oncology Associates, P.A.
Brooksville, Florida, United States, 34613
Medical Specialist of Palm Beaches
Lake Worth, Florida, United States, 33467
Ocala Oncology
Ocala, Florida, United States, 34471
Space Coast Medical Center
Titusville, Florida, United States, 32796
United States, Georgia
Atlanta Cancer Care
Roswell, Georgia, United States, 30076
United States, Idaho
Kootenai Cancer Center
Coeur d'Alene, Idaho, United States, 83814q
United States, Indiana
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Iowa
Iowa Blood and Cancer Center
Cedar Rapids, Iowa, United States, 52402
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology Oncology Life Center
Alexandria, Louisiana, United States, 71301
United States, Maryland
National Cancer Institute Center for Cancer Research, Medical Oncology Branch
Bethesda, Maryland, United States, 20892-1182
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Tennessee Cancer Institute
Southaven, Mississippi, United States, 38671
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
Richmond University Medical Center
Staten Island, New York, United States, 10310
United States, North Carolina
Cancer Care of WNC
Asheville, North Carolina, United States, 28801
Allergy Partners of West North Carolina
Asheville, North Carolina, United States, 28801
United States, Ohio
Gabrail Cancer Center Research LLC
Canton, Ohio, United States, 44718
United States, Oklahoma
Optim Oncology
Midwest City, Oklahoma, United States, 73110
United States, South Carolina
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
University of Tennessee Cancer Institute
Bartlett, Tennessee, United States, 38133
University of Tennessee Cancer Institute
Germantown, Tennessee, United States, 38138
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
United States, Texas
Texas Cancer Center Abilene, Texas Oncology P.A.
Abilene, Texas, United States, 79606
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230
Allison Cancer Center, Texas Oncology, P.A.
Midland, Texas, United States, 79701
Tyler Cancer Center, Texas Oncology
Tyler, Texas, United States, 75702
United States, Washington
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Res Ctr/Univ. of Washington Med Ctr
Seattle, Washington, United States, 98109
United States, West Virginia
Davis Memorial Cancer Care Center
Elkins, West Virginia, United States, 26241
United States, Wisconsin
Marshfield Clinic Weston Center
Weston, Wisconsin, United States, 54476
Canada, Alberta
University of Alberta Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Hungary, 1529
Semmelweis Egyetem Pulmonológiai Klinika
Budapest, Hungary, 1125
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, Hungary, 1121
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza
Deszk, Hungary, 6772
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza
Nyíregyháza, Hungary, 4412
Fejér Megyei Szent György Kórház
Székesfehérvár, Hungary, 8000
Pest Megyei Tüdőgyógyintézet
Törökbálint, Hungary, 2045
India
Gujarat Cancer Hospital and Research Institute
Ahmedabad, India, 380016
SEAROC Cancer Center, S.K.
Jaipur, India, 302013
Tata Memorial Hospital
Mumbai, India, 400012
Noble Hospital
Pune, India
Netherlands
Ziekenhuis Groep Twente - locatie Twenteborg Ziekenhuis
Almelo, Netherlands, 7609 PP
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Universitair Medisch Centrum Maastricht
Maastricht, Netherlands
Poland
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku
Gdansk, Poland, 80-952
Samodzielny Publiczny Szpital Kliniczny nr 4
Lublin, Poland, 20-954
Wielkopolskie Centrum Pulmunologii i Torakochirurgii
Poznan, Poland, 60-569
Centrum Onkologii - Instytut im.Marii Sklodowskiej-Curie
Warsaw, Poland, 02-784
Dolnoslaskie Centrum Chorob Pluc
Wroclaw, Poland, 53-439
Serbia
Klinicko-bolnicki centar Bezanijska kosa
Belgrade, Serbia, 11000
Klinicki Centar Nis
Nis, Serbia, 18000
Institute for pulmonary disease Sremska Kamenica
Sremska Kamenica, Serbia, 21204
United Kingdom
Clatterbridge Centre for Oncology
Bebington, Wirral, United Kingdom, CH63 4JY
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Guy's Hospital
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
NovaRx Corporation
  More Information

Additional Information:
Publications:
Responsible Party: Habib Fakhrai, Ph.D., President & Executive Vice Chairman, NovaRx Corporation
ClinicalTrials.gov Identifier: NCT00676507     History of Changes
Obsolete Identifiers: NCT00641966
Other Study ID Numbers: NR001-03, BB-IND 8868
Study First Received: May 8, 2008
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
India: Central Drugs Standard Control Organization

Keywords provided by NovaRx Corporation:
Gene therapy
Flow cytometry
Immunoenzyme technique
Laboratory biomarker analysis
Quality-of-life-assessment
Tumor cell-derivative vaccine therapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014