Phase IIb Randomized Controlled Study of BLP25 Liposome Vaccine for Immunotherapy of Non-Small Cell Lung Cancer (Stimuvax)
This study has been completed.
Sponsor:
Merck KGaA
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00157209
First received: September 8, 2005
Last updated: August 8, 2012
Last verified: August 2012
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Purpose
This is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with BLP25 liposome vaccine (L-BLP25) for the treatment of patients with stage IIIB or stage IV non-small cell lung cancer (NSCLC). To be eligible, patients entering the trial will have demonstrated either stable disease or a clinical response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy) and have an ECOG performance status of 0, 1 or 2. Following a 3 week washout period, patients will be stratified by disease status (either stage IIIB locoregional disease or stage IIIB with malignant pleural effusion and stage IV), and randomized to either best supportive care (BSC) plus L-BLP25 treatment or BSC alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung |
Biological: BLP25 Liposome Vaccine plus best supportive care Other: Best Supportive Care (BSC) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Phase IIb Randomized, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Merck KGaA:
Primary Outcome Measures:
- Document safety profile of 930 μg of L-BLP25. [ Time Frame: Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 43, 49, 55, Month 24. Additional inquires on survival until death. ] [ Designated as safety issue: No ]
- Compare survival of patients who receive Best Supportive Care plus L-BLP25 to that of patients who receive Best Supportive Care alone. [ Time Frame: Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 43, 49, 55, Month 24. Additional inquires on survival until death. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the impact of L-BLP25 therapy on patients' health-related Quality of Life. [ Time Frame: Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 43, 49, 55, Month 24. Additional inquires on survival until death. ] [ Designated as safety issue: No ]
- To measure the immune responses elicited by L-BLP25. [ Time Frame: Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 43, 49, 55, Month 24. Additional inquires on survival until death. ] [ Designated as safety issue: No ]
| Enrollment: | 171 |
| Study Start Date: | August 2000 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: BLP25 Liposome Vaccine plus best supportive care
Arm 1 will receive best supportive care (BSC) plus BLP25 Liposome vaccine treatment following first-line chemotherapy plus/minus radiotherapy. The primary treatment consists of:
|
| 2 |
Other: Best Supportive Care (BSC)
Arm 2 will receive BSC following first-line chemotherapy plus/minus radiotherapy. BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Stage IIIB or stage IV NSCLC
- Stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. Patients must have completed the first-line treatment at least 3 weeks prior to study entry
- ECOG performance status of ≤2
- Ability to understand and willingness to sign a written informed consent
Exclusion Criteria:
- Received immunotherapy within 4 weeks prior to study entry
- Received immunosuppressive drugs within 3 weeks prior to study entry
- Patients with known brain metastases
- Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- Autoimmune disease or immunodeficiency
- Clinically significant hepatic, renal or cardiac dysfunction
- Patients with clinically significant active infection
- Pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT00157209 History of Changes |
| Other Study ID Numbers: | B25-LG-304 / EMR 63325-005 |
| Study First Received: | September 8, 2005 |
| Last Updated: | August 8, 2012 |
| Health Authority: | Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013