Clinical trial NCT00516685: Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
Keywords: LUNG CANCER
NSCLC
EGF
CANCER VACCINE
IMMUNOTHERAPY
Lead sponsor: Bioven Sdn. Bhd.
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Survival
timeFrame: Two and a half years
Secondary outcomes:
measure: Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life
timeFrame: Two and a half years
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Local Institution
state: Kelantan
city: Nilai
country: Malaysia
facility: Local Institution
state: Negeri Sembilan
city: Kuantan
country: Malaysia
facility: Local Institution
state: Pahang
city: Georgetown
country: Malaysia
facility: Local Institution
state: Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Local Institution
state: Sabah
city: Kota Kinabalu
country: Malaysia
facility: Local Institution
state: Sabah
city: Klang
country: Malaysia
facility: Local Institution
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Local Institution
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
Study officials:
affiliation: NILAI CANCER INSTITUTE
name: G SELVARATNAM, MD
role: PRINCIPAL_INVESTIGATOR
References: