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Safety Study of BLP25 Liposome Vaccine in Non-Small Cell Lung Cancer Patients With Unresectable Stage III Disease (Stimuvax)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00157196
First received: September 8, 2005
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

The primary objective is to document the safety of L-BLP25 phase III formulation in NSCLC patients with unresectable Stage III disease. This population includes Stage IIIA NSCLC patients, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of patients treated.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
 Biological: BLP25 Liposome Vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Safety [ Time Frame: Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 42, Months 12, 18, 24. Additional inquires on survival until death. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Day 0, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 13, 19, 25, 31, 37, 42, Months 12, 18, 24. Additional inquires on survival until death. ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: April 2005
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: BLP25 Liposome Vaccine

    Patients will receive L BLP25 treatment following primary therapy. The primary treatment consists of:

    • A single intravenous (I.V.) administration of 300 mg/m2 of cyclophosphamide three days before the first vaccine treatment. The maximum dose to be administered is 600 mg of cyclophosphamide.
    • Eight weekly subcutaneous vaccinations with 930 µg of L BLP25 at weeks 0, 1, 2, 3, 4, 5, 6 and 7. The 930 µg dose of L BLP25 will consist of four 0.5 mL subcutaneous injections each containing one fourth of the total dose and administered in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen.
    • Best Standard of Care (BSC) will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies. Patients will be discontinued from the study drug upon documented clinical progression.
  Eligibility

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

Inclusion Criteria:

  • Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement must be confirmed by biopsy
  • Stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage III disease

  • Primary therapy should be a minimum of 2 cycles of Platinum-based first-line chemotherapy, given concurrent with thoracic radiation. The combined modality should consist of either:

    • induction (2 cycles) chemotherapy followed by concurrent chemo/RT; or
    • concurrent chemo/RT followed by 2 cycles of consolidation chemotherapy; or
    • concurrent chemo/RT alone
  • A minimum radiation dose of ≥6,000cGy should be administered. Patients must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
  • ECOG performance status of ≤1
  • Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

  • Undergone lung cancer specific therapy (including surgery) prior to primary chemo/RT
  • Received immunotherapy within 4 weeks prior to study entry
  • Received systemic immunosuppressive drugs within 4 weeks prior to study entry
  • Received investigational systemic drugs within 4 weeks prior to study entry
  • Brain metastases
  • Pleural effusion, unless cytologically confirmed to be non-malignant
  • 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
  • Clinically significant active infection
  • Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157196

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: NCT00157196     History of Changes
Other Study ID Numbers: B25-LG-305 / EMR 63325-006
Study First Received: September 8, 2005
Last Updated: August 8, 2012
Health Authority: Canada: Health Canada

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 17, 2013