Immunotherapy With TG4010 in Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transgene
ClinicalTrials.gov Identifier:
NCT00415818
First received: December 22, 2006
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Biological: MVA-MUC1-IL2
Drug: 1st line Chemotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010(MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Transgene:

Primary Outcome Measures:
  • Progression free survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response Rate according to WHO criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: December 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
MVA-MUC1-IL2 in combination with 1st line Chemotherapy
Biological: MVA-MUC1-IL2

MVA-MUC1-IL2:

Dose of 10exp8 plaque forming units (pfu).

Chemotherapy:

Arm 1 and Arm 2 Intravenous CT: cisplatin (75mg/m² at Day 1) and gemcitabine (1250mg/m² at Days 1 and 8) every 3 weeks, for up to six cycles or until progressive disease, whichever occurred first.

Drug: 1st line Chemotherapy
Active Comparator: Arm 2
1st line Chemotherapy without a MVA-MUC1-IL2 combination
Drug: 1st line Chemotherapy

Detailed Description:

In the experimental arm patients receive subcutaneous injections of TG4010 at the dose of 108 pfu in combination with chemotherapy treatment whereas patients in the control arm receive chemotherapy alone. The chemotherapy associates cisplatin and gemcitabine and is given for up to 6 cycles or progressive disease, whichever occurs first.

TG4010 is administered once per week for 6 weeks, then once every 3 weeks in combination with chemotherapy and thereafter as monotherapy until documentation of progressive disease.

Tumor response will be evaluated every 6 weeks by a CT-scan and results will be available before starting an additional treatment period of 6 weeks. The tumor response taken into account will be for each patient the best overall response obtained during the study.

The endpoint of the study is based on Progression Free Survival (PFS) at 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed non-small cell carcinoma of the lung (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma);
  • Histological documentation of MUC1 antigen expression on the primary tumor or on metastasis, as defined by a positive staining by immuno-histo-chemistry in at least 25% of the tumor cells in the conditions described in the technical documentation of the monoclonal antibody;
  • Patients will have stage IIIb "wet" (with pleural or pericardial effusion) or IV disease, with no prior systemic therapy for advanced disease except for adjuvant treatment. Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted;
  • At least one measurable lesion by Computed Tomography (CT-scanner) according to WHO criteria (lesion accurately measured in two dimensions with longest diameter equal or greater to 10 mm with spiral CT scan);
  • Adequate hematological, hepatic, and renal function:

    • Hemoglobin >= 10.0 g/dL; WBC >= 3.0x10e9/L including neutrophils >= 1.5x10e9/L and total lymphocytes count >= 0.5x10e9/L; platelets count >= 100x10e9/L;
    • Bilirubin =< 2x the upper limit of normal and serum transaminases =< 3x the upper limit of normal;
    • Glomerular Filtration Rate higher than 60 ml/mn according to Cockcroft formula;
  • Performance status 0 or 1 on the ECOG scale (Appendix 2);
  • Minimum estimated life expectancy of 4 months;
  • Written informed consent from patient.

Exclusion Criteria:

  • Concomitant brain metastases. If previous brain metastases were treated, the absence of evolution is to be demonstrated by the MRI or scanner performed at baseline;
  • Prior history of other malignancy except basal cell carcinoma and intra-epithelial cervical cancer or other cancer with complete response since at least 5 years;
  • History of any form of systemic therapy for advanced non-small cell cancer of the lung except for (neo)adjuvant treatment;
  • Previous (within 4 weeks prior to day 1) or concomitant long term treatment with systemic steroids, immunosuppressive / immunomodulating drugs (e.g. Cyclosporine, corticoïds);
  • Positive serology for HIV or HCV; positive antigens for hepatitis B;
  • Serious concomitant medical disorder;
  • Major surgery within 4 weeks prior to day 1;
  • Patient with an organ allograft;
  • Allergy to eggs;
  • Participation in another experimental protocol during the study period, or within 4 weeks prior to day 1;
  • Pregnancy at the entry or women who are breast feeding;
  • Patient without adequate protection against pregnancy during the conduct of the study and for 3 months after the last injection of TG4010 and/or chemotherapy;
  • History of substance abuse;
  • Patient unable or unwilling to comply with the protocol requirements.
  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: NCT00415818

Locations
France
Centre Hospitalier Belfort-Montbeliard
Belfort, France, 90016
CHU, Service de Pneumologie
Besancon, France, 25000
Centre Hospitalier Général, Service de Pneumologie
Briey, France, 54151
Centre François Baclesse
Caen, France, 14076
Hôpital Pasteur - Service de médecine F- Pavillon 43
Colmar, France, 68000
Centre Oscar Lambret
Lille, France, 59020
Institut Paoli-Calmettes, Service d'oncologie médicale
Marseille, France, 13273
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
CHRU Hôpital de Pontchaillou
Rennes, France, 35033
Hôpital Lyautey - Service de Pneumologie
Strasbourg, France, 67100
Centre Hospitalier de la Haute Saône, Service de Pneumologie - Allergologie
Vesoul, France, 70014
Germany
Asklepios Fachkliniken, Zentrum für Pneumonologie
Gauting, Germany, 82131
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
Lungenklinik Krankenhaus Merheim
Köln, Germany, 51109
Klinikum Mannheim der Ruprecht-Karls
Mannheim, Germany, 68167
Klinikum Offenburg, Medizinische Klinik II
Offenburg, Germany, 77654
Hungary
Fejér Megyei Szent György Kórház
Székesfehérvár, Hungary, 8000
Poland
Oddział II Chorób Płuc i Gruźlicy
Bialystok, Poland, 15-540
Kujawsko-Pomorskie Centrum Pulmonologii
Bydgoszcz, Poland, 85-326
Oddział Chemioterapii
Krakow, Poland, 31-826
Oddział III Chorób Płuc i Gruźlicy
Otwock, Poland, 05-400
Oddział Onkologii Klinicznej
Poznan, Poland, 60-569
Dolnośląskie Centrum
Wrocław, Poland, 53-439
Sponsors and Collaborators
Transgene
Investigators
Principal Investigator: Elisabeth QUOIX, M.D. Hôpital Lyautey, Service de Pneumologie
  More Information

Additional Information:
Publications:
Responsible Party: Transgene
ClinicalTrials.gov Identifier: NCT00415818     History of Changes
Other Study ID Numbers: TG4010.09
Study First Received: December 22, 2006
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Germany: Paul-Ehrlich-Institut

Keywords provided by Transgene:
Lung Cancer
NSCLC
Cancer Vaccine
Stage IV Non-Small Cell Lung Cancer
Stage IIIb Non-Small Cell Lung Cancer with effusion

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014