Phase IIb Randomized Controlled Study of BLP25 Liposome Vaccine for Immunotherapy of Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00157209

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cyclophosphamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Phase IIb Randomized, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Document safety profile of 1000 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:	166
Study Start Date:	August 2000
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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 1,000 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.

Arms

Assigned Interventions

1: Experimental

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 1,000 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157209

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Martin Falk, MD

Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

More Information

Responsible Party:	EMD Serono ( Bruce Gaumond, Sr. Clinical Project Manager )
Study ID Numbers:	B25-LG-304 / EMR 63325-005
Study First Received:	September 8, 2005
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00157209
Health Authority:	Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Cyclophosphamide
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009