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

August 14, 2007
September 29, 2011
July 2007
Not Provided
Survival [ Time Frame: Two and a half years ] [ Designated as safety issue: No ]
Survival [ Time Frame: Two and a half years ]
Complete list of historical versions of study NCT00516685 on ClinicalTrials.gov Archive Site
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 ]
Safety, immunogenicity and preliminary efficacy assessment [ Time Frame: Two and a half years ]
Not Provided
Not Provided
 
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
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

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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
  • 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.
    Intervention: Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
  • No Intervention: Control Group
    Patients in this arm will only receive Best Supportive Care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
230
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT00516685
CT 07-03
Not Provided
DR G SELVARATNAM, NILAI CANCER INSTITUTE
Bioven Sdn. Bhd.
Not Provided
Principal Investigator: G SELVARATNAM, MD NILAI CANCER INSTITUTE
Bioven Sdn. Bhd.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP