search
Back to results

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

Primary Purpose

Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV

Status
Terminated
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Recombinant Human rEGF-P64K/Montanide Vaccine
Sponsored by
Bioven Sdn. Bhd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV focused on measuring LUNG CANCER, NSCLC, EGF, CANCER VACCINE, IMMUNOTHERAPY

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vaccine Group

Control Group

Arm Description

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.

Patients in this arm will only receive Best Supportive Care.

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life

Full Information

First Posted
August 14, 2007
Last Updated
September 29, 2011
Sponsor
Bioven Sdn. Bhd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00516685
Brief Title
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
Acronym
NSCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bioven Sdn. Bhd.

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
Keywords
LUNG CANCER, NSCLC, EGF, CANCER VACCINE, IMMUNOTHERAPY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaccine Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in this arm will only receive Best Supportive Care.
Intervention Type
Biological
Intervention Name(s)
Recombinant Human rEGF-P64K/Montanide Vaccine
Primary Outcome Measure Information:
Title
Survival
Time Frame
Two and a half years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G SELVARATNAM, MD
Organizational Affiliation
NILAI CANCER INSTITUTE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Institution
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Local Institution
City
Nilai
State/Province
Negeri Sembilan
ZIP/Postal Code
71800
Country
Malaysia
Facility Name
Local Institution
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Local Institution
City
Georgetown
State/Province
Pulau Pinang
ZIP/Postal Code
11200
Country
Malaysia
Facility Name
Local Institution
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88838
Country
Malaysia
Facility Name
Local Institution
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Local Institution
City
Klang
State/Province
Selangor
ZIP/Postal Code
41000
Country
Malaysia
Facility Name
Local Institution
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Local Institution
City
Kuala Lumpur
ZIP/Postal Code
51900
Country
Malaysia
Facility Name
Local Institution
City
Kuala Lumpur
ZIP/Postal Code
53000
Country
Malaysia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs