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Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: April 2, 2007   Last Updated: August 20, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00455572
  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
Tumor Antigen-positive Non-Small Cell Lung Cancer
Biological: Immunotherapeutic GSK1572932A
Drug: Cisplatin (CDDP)
Drug: Vinorelbine
Procedure: Radiotherapy
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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-protein D 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 ]
  • The anti-MAGE-A3 seroconversion [ Time Frame: After the fourth dose of ASCI and at the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: May 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort 1: Experimental
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
Cohort 4: Experimental
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
Cohort 2: Experimental
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
Cohort 3: Experimental
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

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. 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 4-8 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 2-4 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
  • In France only: a patient will be eligible for inclusion in this study if either affiliated to or beneficiary of a social security category

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455572

  Show 26 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 107240
Study First Received: April 2, 2007
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00455572     History of Changes
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   France: Afssaps - French Health Products Safety Agency;   Canada: Health Canada;   Italy: ISS: Instituto Superiori di Sanita;   Germany: Paul-Ehrlich-Institut

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

Study placed in the following topic categories:
Thoracic Neoplasms
Vinorelbine
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adjuvants, Immunologic
Non-small Cell Lung Cancer
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009