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

NCT00676507 | Completed Phase 3 DMC

• 2 other identifiers: NR001-03BB-IND 8868
• Study Type: interventional
• Target: 532
• Locations: 8 countries
• Sites: 82

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.

Conditions

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

Keywords

Gene therapy; Flow cytometry; Immunoenzyme technique; Laboratory biomarker analysis; Quality-of-life-assessment; Tumor cell-derivative vaccine therapy

Outcome Measures

Primary Outcomes (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 Outcomes (7)

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

  3 years

• 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

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

  3 years

• Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to treatment in the Best Supportive Care control group.

  3 years

• Evaluate the response duration in subjects treated with Lucanix™ compared to the Best Supportive Care control group.

  3 years

Study Arms (2)

Treatment

EXPERIMENTAL

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™

Control Arm

PLACEBO COMPARATOR

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

Interventions

Lucanix™ BIOLOGICAL

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.

Also known as: belagenpumatucel-L

Treatment

Placebo Comparator OTHER

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.

Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovaRx Corporation: lead

Study Sites (82)

Southern Cancer Center

Mobile, Alabama, 36608, United States

Location

Alaska Regional Hospital

Anchorage, Alaska, 99508, United States

Location

Mayo Clinic Cancer Center

Scottsdale, Arizona, 85259, United States

Location

Clopton Clinic Hematology/Oncology

Jonesboro, Arkansas, 72401, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

UCLA Pasadena Oncology

Pasadena, California, 91105, United States

Location

Cancer Care Associates

Redondo, California, 90277, United States

Location

Innovative Research Center of California

San Diego, California, 92103, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

UCLA Cancer Center

Santa Monica, California, 90404, United States

Location

UCLA Cancer Center-Valencia

Valencia, California, 91355, United States

Location

UCLA Cancer Center

Westlake Village, California, 91361, United States

Location

University of Colorado Health Science Center

Aurora, Colorado, 80045, United States

Location

Pasco Hernando Oncology Associates, P.A.

Brooksville, Florida, 34613, United States

Location

Medical Specialist of Palm Beaches

Lake Worth, Florida, 33467, United States

Location

Ocala Oncology

Ocala, Florida, 34471, United States

Location

Space Coast Medical Center

Titusville, Florida, 32796, United States

Location

Atlanta Cancer Care

Roswell, Georgia, 30076, United States

Location

Kootenai Cancer Center

Coeur d'Alene, Idaho, 83814q, United States

Location

St. Francis Medical Group Oncology and Hematology Specialists

Indianapolis, Indiana, 46237, United States

Location

Iowa Blood and Cancer Center

Cedar Rapids, Iowa, 52402, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Hematology Oncology Life Center

Alexandria, Louisiana, 71301, United States

Location

National Cancer Institute Center for Cancer Research, Medical Oncology Branch

Bethesda, Maryland, 20892-1182, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Tennessee Cancer Institute

Southaven, Mississippi, 38671, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89074, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Eastchester Center for Cancer Care

The Bronx, New York, 10469, United States

Location

Allergy Partners of West North Carolina

Asheville, North Carolina, 28801, United States

Location

Cancer Care of WNC

Asheville, North Carolina, 28801, United States

Location

Gabrail Cancer Center Research LLC

Canton, Ohio, 44718, United States

Location

Optim Oncology

Midwest City, Oklahoma, 73110, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29605, United States

Location

University of Tennessee Cancer Institute

Bartlett, Tennessee, 38133, United States

Location

University of Tennessee Cancer Institute

Germantown, Tennessee, 38138, United States

Location

University of Tennessee Cancer Institute

Memphis, Tennessee, 38104, United States

Location

Texas Cancer Center Abilene, Texas Oncology P.A.

Abilene, Texas, 79606, United States

Location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

Location

Allison Cancer Center, Texas Oncology, P.A.

Midland, Texas, 79701, United States

Location

Tyler Cancer Center, Texas Oncology

Tyler, Texas, 75702, United States

Location

Seattle Cancer Care Alliance/Fred Hutchinson Cancer Res Ctr/Univ. of Washington Med Ctr

Seattle, Washington, 98109, United States

Location

Davis Memorial Cancer Care Center

Elkins, West Virginia, 26241, United States

Location

Marshfield Clinic Weston Center

Weston, Wisconsin, 54476, United States

Location

University of Alberta Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, 1121, Hungary

Location

Semmelweis Egyetem Pulmonológiai Klinika

Budapest, 1125, Hungary

Location

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, 1529, Hungary

Location

Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza

Deszk, 6772, Hungary

Location

Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórháza

Nyíregyháza, 4412, Hungary

Location

Fejér Megyei Szent György Kórház

Székesfehérvár, 8000, Hungary

Location

Pest Megyei Tüdőgyógyintézet

Törökbálint, 2045, Hungary

Location

Gujarat Cancer Hospital and Research Institute

Ahmedabad, 380016, India

Location

SEAROC Cancer Center, S.K.

Jaipur, 302013, India

Location

Tata Memorial Hospital

Mumbai, 400012, India

Location

Noble Hospital

Pune, India

Location

Ziekenhuis Groep Twente - locatie Twenteborg Ziekenhuis

Almelo, 7609 PP, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Location

Universitair Medisch Centrum Maastricht

Maastricht, Netherlands

Location

Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku

Gdansk, 80-952, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, 20-954, Poland

Location

Wielkopolskie Centrum Pulmunologii i Torakochirurgii

Poznan, 60-569, Poland

Location

Centrum Onkologii - Instytut im.Marii Sklodowskiej-Curie

Warsaw, 02-784, Poland

Location

Dolnoslaskie Centrum Chorob Pluc

Wroclaw, 53-439, Poland

Location

Klinicko-bolnicki centar Bezanijska kosa

Belgrade, 11000, Serbia

Location

Institute for pulmonary disease Sremska Kamenica

Kamenitz, 21204, Serbia

Location

Klinicki Centar Nis

Niš, 18000, Serbia

Location

The Beatson West of Scotland Cancer Centre

Glasgow, Glasgow, G12 0YN, United Kingdom

Location

Clatterbridge Centre for Oncology

Bebington, Wirral, CH63 4JY, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Related Publications (4)

• Fakhrai H, Mantil JC, Liu L, Nicholson GL, Murphy-Satter CS, Ruppert J, Shawler DL. Phase I clinical trial of a TGF-beta antisense-modified tumor cell vaccine in patients with advanced glioma. Cancer Gene Ther. 2006 Dec;13(12):1052-60. doi: 10.1038/sj.cgt.7700975. Epub 2006 Jul 7.

  PMID: 16826191 BACKGROUND

• Nemunaitis J, Nemunaitis M, Senzer N, Snitz P, Bedell C, Kumar P, Pappen B, Maples PB, Shawler D, Fakhrai H. Phase II trial of Belagenpumatucel-L, a TGF-beta2 antisense gene modified allogeneic tumor vaccine in advanced non small cell lung cancer (NSCLC) patients. Cancer Gene Ther. 2009 Aug;16(8):620-4. doi: 10.1038/cgt.2009.15. Epub 2009 Mar 13.

  PMID: 19287371 BACKGROUND

• Nemunaitis J, Dillman RO, Schwarzenberger PO, Senzer N, Cunningham C, Cutler J, Tong A, Kumar P, Pappen B, Hamilton C, DeVol E, Maples PB, Liu L, Chamberlin T, Shawler DL, Fakhrai H. Phase II study of belagenpumatucel-L, a transforming growth factor beta-2 antisense gene-modified allogeneic tumor cell vaccine in non-small-cell lung cancer. J Clin Oncol. 2006 Oct 10;24(29):4721-30. doi: 10.1200/JCO.2005.05.5335. Epub 2006 Sep 11.

  PMID: 16966690 RESULT

• Giaccone G, Bazhenova LA, Nemunaitis J, Tan M, Juhasz E, Ramlau R, van den Heuvel MM, Lal R, Kloecker GH, Eaton KD, Chu Q, Dunlop DJ, Jain M, Garon EB, Davis CS, Carrier E, Moses SC, Shawler DL, Fakhrai H. A phase III study of belagenpumatucel-L, an allogeneic tumour cell vaccine, as maintenance therapy for non-small cell lung cancer. Eur J Cancer. 2015 Nov;51(16):2321-9. doi: 10.1016/j.ejca.2015.07.035. Epub 2015 Aug 14.

  PMID: 26283035 DERIVED

Related Links

• Main sponsor website
• Clinical trial information

MeSH Terms

Conditions

Lung Neoplasms

Interventions

belagenpumatucel L

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 13, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (53); SE (3); IN (4); CA (2); NL (4); GB (4); PL (5); HU (7)