Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer

This study has been terminated.
(Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the study.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00455572
First received: April 2, 2007
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Lung Cancer, Non-Small Cell
Biological: Immunotherapeutic GSK1572932A
Drug: Cisplatin (CDDP)
Drug: Vinorelbine
Procedure: Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The anti-MAGE-A3 seroconversion [ Time Frame: After the fourth dose of ASCI and at the end of treatment ] [ Designated as safety issue: No ]
  • The anti-protein D seroconversion [ Time Frame: After the fourth dose of ASCI and at the end of treatment ] [ Designated as safety issue: No ]
  • The anti-CpG seroconversion [ Time Frame: After the fourth dose of ASCI and at the end of treatment ] [ Designated as safety issue: No ]
  • The MAGE-A3 cellular (T cell) response [ Time Frame: After the fourth dose of ASCI and at the end of treatment ] [ Designated as safety issue: No ]
  • Occurrence of adverse events, including abnormal hematological and biochemical laboratory values [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the study ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: May 2007
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel.
Biological: Immunotherapeutic GSK1572932A
Intramuscular injection, 8 doses
Drug: Cisplatin (CDDP)
Four cycles with doses based on patient's body surface area, intravenous administration
Drug: Vinorelbine
Four cycles with doses based on patient's body surface area , intravenous administration
Experimental: Cohort 2
Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy
Biological: Immunotherapeutic GSK1572932A
Intramuscular injection, 8 doses
Drug: Cisplatin (CDDP)
Four cycles with doses based on patient's body surface area, intravenous administration
Drug: Vinorelbine
Four cycles with doses based on patient's body surface area , intravenous administration
Experimental: Cohort 3
Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only.
Biological: Immunotherapeutic GSK1572932A
Intramuscular injection, 8 doses
Experimental: Cohort 4
Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only.
Biological: Immunotherapeutic GSK1572932A
Intramuscular injection, 8 doses
Drug: Cisplatin (CDDP)
Four cycles with doses based on patient's body surface area, intravenous administration
Drug: Vinorelbine
Four cycles with doses based on patient's body surface area , intravenous administration
Procedure: Radiotherapy
Regimen will be based upon the site's own standard procedures

Detailed Description:

This is an open, four-arm, parallel-group study, to be conducted at approximately 20 centers in Europe and Canada. All patients will receive the same immunotherapeutic treatment with GSK1572932A, but they will be recruited into four cohorts according to the details of their disease. Cohort 1: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will receive chemo-and immunotherapy in parallel. Cohort 2: Patients with resected stage IB, II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine. These patients will first receive chemotherapy and then immunotherapy.

Cohort 3: Patients with resected stage IB, II or IIIA tumors who are not due for chemotherapy. These patients will receive immunotherapy only. Cohort 4: Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only. Immunotherapeutic treatment will comprise eight doses of GSK1572932A. Doses will be administered at three-week intervals; in Cohort 1 this may be adapted to fit in with the patient's chemotherapy. During the study, adjuvant radiotherapy is allowed in Cohorts 1, 2 and 3 for patients in stage III only and is prohibited in Cohort 4. Chemotherapy during the study is allowed in Cohort 1 only as described above, and is prohibited in Cohorts 2-4. The total maximum duration of the study for a patient will be 30-35 weeks.

  Eligibility

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

Inclusion Criteria:

  • Written informed consent obtained,
  • Aged 18 or more,
  • Pathologically proven stage IB, II or III NSCLC,
  • Tumor expresses MAGE-A3,
  • Free of distant metastasis,
  • For Cohort 1, all of the following:

    1. Completely resected stage IB, II or IIIA NSCLC,
    2. Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
    3. ECOG performance status = 0 or 1
    4. Due to receive adjuvant chemotherapy as permitted in the protocol
    5. Not received, not receiving, and not due to receive adjuvant radiotherapy (except stage III patients)
    6. First administration of chemotherapy can be scheduled within 4-12 weeks after surgery
  • For Cohort 2, all of the following:

    1. Resected stage IB, II or IIIA NSCLC,
    2. Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
    3. ECOG PS = 0 or 1
    4. Due to receive, or receiving, adjuvant chemotherapy as permitted in the protocol
    5. Not received, not receiving, and not due to receive, adjuvant radiotherapy (except stage III patients)
    6. First administration of ASCI treatment can be scheduled within 2-4 weeks after the last administration of chemotherapy
    7. Received at least 2 cycles of standard chemotherapy before ASCI treatment is initiated, whereafter no further chemotherapy is planned
  • For Cohort 3, all of the following:

    1. Resected stage IB, II or IIIA NSCLC
    2. Anatomical tumor resection, involving at least a lobectomy, and nodal sampling as per center standard
    3. ECOG PS = 0 or 1 or 2
    4. Not received, not receiving, and not due to receive, adjuvant chemotherapy
    5. Not received, not receiving, and not due to receive, adjuvant radiotherapy (this does not apply to patients in stage III)
    6. First administration of ASCI treatment can be scheduled within 4-8 weeks after surgery
  • For Cohort 4, all of the following:

    1. Unresectable stage III NSCLC
    2. ECOG PS = 0 or 1 or 2
    3. Due to receive, or receiving, chemo- and radiotherapy according to institution standard
    4. Received at least 2 cycles of standard chemotherapy before the initiation of ASCI treatment, whereafter no further chemo-/radiotherapy is planned
    5. Stable disease or objective response (confirmed by CT scan) after standard chemo-/radiotherapy
    6. Administration of ASCI treatment can be scheduled within 2-6 weeks after the last administration of chemo-/radiotherapy
  • Laboratory criteria: adequate bone-marrow reserve, adequate renal function, adequate hepatic function.
  • For females: EITHER not of child-bearing potential, OR sexually abstinent, OR negative urine pregnancy test + use of adequate contraceptive precautions from 30 days before first study treatment till 2 months after completion of study treatment course
  • In the view of the investigator, the patient can and will comply with the requirements of the protocol

Exclusion criteria:

  • Previous or concomitant other malignancies, except if effectively treated and considered by the investigator highly likely to have been cured
  • Pregnant or lactating
  • History of anaphylaxis or severe allergic reaction
  • Concurrent severe medical problems, unrelated to the malignancy, limiting full compliance with the study or exposing the patient to unacceptable risk
  • Psychiatric or addictive disorders compromising the ability to give informed consent, or to comply with the trial procedures
  • HIV-positive
  • Require treatment with systemic corticosteroids, or other immunosuppressive agents
  • Need home oxygenation
  • Received or plan to receive investigational or non-registered product other than the study medication from 30 days before first dose of study medication and during whole study period
  • History of chronic alcohol consumption and/or drug abuse
  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: NCT00455572

Locations
Belgium
GSK Investigational Site
Genk, Belgium, 3600
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liège, Belgium, 4000
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
GSK Investigational Site
Greenfield Park, Quebec, Canada, J4V 2H1
GSK Investigational Site
Montreal, Quebec, Canada, H4J 1C5
France
GSK Investigational Site
Montpellier, France, 34295
GSK Investigational Site
Pierre Benite, France, 69495
GSK Investigational Site
Saint Herblain, France, 44805
GSK Investigational Site
Strasbourg, France, 67091
Germany
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
GSK Investigational Site
Bad Berka, Thueringen, Germany, 99437
GSK Investigational Site
Hamburg, Germany, 20246
Italy
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
GSK Investigational Site
Roma, Lazio, Italy, 00152
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Milano, Lombardia, Italy, 20132
GSK Investigational Site
Milano, Lombardia, Italy, 20141
United Kingdom
GSK Investigational Site
Wythenshawe, Greater Manchester, United Kingdom, M23 9LT
GSK Investigational Site
Bebington, Wirral, United Kingdom, CH63 4JY
GSK Investigational Site
London, United Kingdom, SE1 9RT
GSK Investigational Site
Nottingham, United Kingdom, NG5 1PB
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00455572     History of Changes
Other Study ID Numbers: 107240
Study First Received: April 2, 2007
Last Updated: August 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Italy: ISS: Instituto Superiori di Sanita
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Immunotherapeutic
Adjuvant cancer therapy
Non-small-cell lung cancer
ASCI

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 20, 2014