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

Bioven

Status and phase: Terminated; Phase 3; Phase 2

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

Treatments: Biological: Recombinant Human rEGF-P64K/Montanide Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516685

CT 07-03

Details and patient eligibility

About

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).

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Vaccine Group

Experimental group

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.

Treatment:

Biological: Recombinant Human rEGF-P64K/Montanide Vaccine

Control Group

No Intervention group

Description:

Patients in this arm will only receive Best Supportive Care.