Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy (STOP)
This study is ongoing, but not recruiting participants.
Sponsor:
NovaRx Corporation
Information provided by:
NovaRx Corporation
ClinicalTrials.gov Identifier:
NCT00676507
First received: May 8, 2008
Last updated: May 29, 2012
Last verified: May 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676507
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| 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 | |
| Santa Barbara Hematology Oncology Medical Group, Inc. | |
| Santa Barbara, California, United States, 93105 | |
| Sansum Clinic | |
| 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, 89128 | |
| Comprehensive Cancer Centers of Nevada | |
| Las Vegas, Nevada, United States, 89169 | |
| 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:
|
Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013