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

Sponsor
NovaRx Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00676507
Collaborator
(none)
532
Enrollment
82
Locations
2
Arms
54
Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Biological: Lucanix™
  • Other: Placebo Comparator
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
532 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo. [7 years]

    Secondary Outcome Measures

    1. Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the Best Support Care control group. [3 years]

    2. 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. [3 years]

    3. Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment within the Best Supportive Care control group. [3 years]

    4. Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the Best Supportive Care control group. [3 years]

    5. Evaluate the response duration in subjects treated with Lucanix™ compared to the Best Supportive Care control group. [3 years]

    6. Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as compared to the Best Supportive Care control group. [7 years]

    7. Adverse events of subjects treated with Lucanix™ will be compared to subjects in the Best Supportive Care control group. [7 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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

    Sponsors and Collaborators

    • NovaRx Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    NovaRx Corporation
    ClinicalTrials.gov Identifier:
    NCT00676507
    Other Study ID Numbers:
    • NR001-03
    • BB-IND 8868
    • NCT00641966
    First Posted:
    May 13, 2008
    Last Update Posted:
    May 8, 2015
    Last Verified:
    May 1, 2015
    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
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of May 8, 2015