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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00455572 |
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 |
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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 |
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 |
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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.
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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
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Cohort 4: Experimental
Patients with unresectable stage III tumors, following standard chemotherapy and/or radiotherapy. These patients will receive immunotherapy only.
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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
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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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For Cohort 1, all of the following:
For Cohort 2, all of the following:
For Cohort 3, all of the following:
For Cohort 4, all of the following:
For females: EITHER not of child-bearing potential, OR sexually abstinent, OR negative urine pregnancy test
Exclusion criteria:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
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 |
Non-small-cell lung cancer Immunotherapeutic Adjuvant cancer therapy ASCI |
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 |
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 |