Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV

This study has been terminated.
(Due to inability of patient enrollment, decision taken to terminate in the interests of patients and later Malaysia is incorporated into global Phase 3 trial.)
Sponsor:
Information provided by:
Bioven Sdn. Bhd.
ClinicalTrials.gov Identifier:
NCT00516685
First received: August 14, 2007
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV non-small-cell lung cancer (NSCLC).


Condition Intervention Phase
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
Phase 2
Phase 3

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 Phase II/III Trial to Assess the Safety, Immunogenicity and Preliminary Efficacy of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Administered to Patients With Non-Small-Cell Lung Cancer (NSCLC) After Receiving Conventional First Line Chemotherapy

Resource links provided by NLM:


Further study details as provided by Bioven Sdn. Bhd.:

Primary Outcome Measures:
  • Survival [ Time Frame: Two and a half years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life [ Time Frame: Two and a half years ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: July 2007
Arms Assigned Interventions
Experimental: Vaccine Group
Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
No Intervention: Control Group
Patients in this arm will only receive Best Supportive Care.

  Eligibility

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

Inclusion Criteria:

  • Patients who have signed the informed consent form.
  • Patients who are eighteen years of age or over with histologically or cytologically confirmed NSCLC in advanced stages IIIb or IV, not amenable to any attempt of curative chemo-radiotherapy and/or surgery.
  • Patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (PET, CT scan, MRI, Rx) or equal or higher 10 mm using CT scan.
  • Patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks.
  • Female patients of reproductive potential must have negative pregnancy tests. Those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or IUD.
  • ECOG status 0 to 2.
  • Patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range.
  • Patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per RECIST.

Exclusion Criteria:

  • Patients who are candidates for combined modality treatment.
  • Patients who are receiving immunosuppressive therapy including corticosteroids.
  • Patients who have received immunotherapy within the previous 3 months.
  • Patients who have participated in a clinical study within the previous 30 days.
  • Patients who may be allergic to any component of the vaccine.
  • Medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol.
  • Patients bearing brain metastasis from the primary lung tumor.
  • Patients bearing a second primary tumor.
  • Patients showing progressive disease after finishing first line chemotherapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516685

Locations
Malaysia
Local Institution
Kubang Kerian, Kelantan, Malaysia, 16150
Local Institution
Nilai, Negeri Sembilan, Malaysia, 71800
Local Institution
Kuantan, Pahang, Malaysia, 25100
Local Institution
Georgetown, Pulau Pinang, Malaysia, 11200
Local Institution
Kota Kinabalu, Sabah, Malaysia, 88996
Local Institution
Kota Kinabalu, Sabah, Malaysia, 88838
Local Institution
Klang, Selangor, Malaysia, 41000
Local Institution
Petaling Jaya, Selangor, Malaysia, 50603
Local Institution
Kuala Lumpur, Malaysia, 51900
Local Institution
Kuala Lumpur, Malaysia, 53000
Sponsors and Collaborators
Bioven Sdn. Bhd.
Investigators
Principal Investigator: G SELVARATNAM, MD NILAI CANCER INSTITUTE
  More Information

No publications provided

Responsible Party: DR G SELVARATNAM, NILAI CANCER INSTITUTE
ClinicalTrials.gov Identifier: NCT00516685     History of Changes
Other Study ID Numbers: CT 07-03
Study First Received: August 14, 2007
Last Updated: September 29, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by Bioven Sdn. Bhd.:
LUNG CANCER
NSCLC
EGF
CANCER VACCINE
IMMUNOTHERAPY

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014