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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Time Frame:

Two and a half years

Safety Issue:

No

Principal Investigator

G SELVARATNAM, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NILAI CANCER INSTITUTE

Authority:

Malaysia: Ministry of Health

Study ID:

CT 07-03

NCT ID:

NCT00516685

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
  • LUNG CANCER
  • NSCLC
  • EGF
  • CANCER VACCINE
  • IMMUNOTHERAPY
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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