Phase IIb Randomized Controlled Study of BLP25 Liposome Vaccine for Immunotherapy of Non-Small Cell Lung Cancer (Stimuvax)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00157209
First received: September 8, 2005
Last updated: August 5, 2014
Last verified: August 2012
  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:

  • A single intravenous (I.V.) administration of 300 mg/m2 of cyclophosphamide (three days before the first vaccine treatment).
  • Eight weekly subcutaneous vaccinations with 930 mg of BLP25 Liposome vaccine at weeks 0, 1, 2, 3, 4, 5, 6 and 7.
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
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: NCT00157209

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Martin Falk, MD Merck KGaA
  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 5, 2014
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 August 19, 2014