Anti-idiotype 1E10 vaccine in advanced non- small cell lung (NSCLC) patients

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000009
• Date of registration: 28/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Anti-idiotype 1E10 vaccine in advanced non- small cell lung (NSCLC) patients
• Scientific title: Phase II study: Active specific immunotherapy with the 1e10 anti idiotype vaccine in the treatment of patients with advanced non small cell lung Cancer
• Date of first enrolment: 27/09/2006
• Target sample size: 176
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000009-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

• Name: MD,PHD Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients that have signed the informed consent. 2. Patients with complete response or with measurable lesions of the disease with partial response or stable when finishing the standard first line of Chemotherapy/Radiotherapy. 3. Patients whose time interval between finishing the oncospecific treatment and starting the vaccination is between 28 and 56 days. 4. Patient age between 18 and 75 years old, both inclusive. 5. General status according to ECOG < 2 (Karnofsky > 60 %). 6. Patients that have normal functioning of organs defined by the following parameters: Hemoglobin>¬ 90 g/L, Total leukocytes count> 3.0 x 109/L, Absolute neutrophils count>1.5 x 109/L, Platelet count>¬100 x 109/L, Total Bilirubin: Within normal limits. TGP and TGO: ¬2.5 times the normal highest institutional limit. Creatinine: Within normal limits for each institution. Blood glucose: Within normal limits for each institution. Total and fractioned proteins: Within normal limits for each institution. 7. Life expectancy of 4 months or more.
Exclusion criteria: 1. Pregnant or breastfeeding patients. 2. Patients that have received any type of immunotherapy for NSCLC. 3. Patients with known hypersensitivity to any component of the formulation. 4. Patients of both sexes in fertile age that are not using an adequate contraceptive method (intrauterine device, hormone contraceptive, barrier methods or tubal ligation). In case of the male sex (vasectomy, use of condom) while treatment duration. 5. Patients that are receiving another research drug. 6. Patients with autoimmune diseases or decompensated chronic diseases. 7. Patients with acute allergic status or history of severe allergic reactions. 8. Patients with brain metastases or other primary neoplastic lesion. 9. Patients with prior history of demyelinizing or inflammatory diseases of the CNS or peripheral nervous system. 10. Patients with intercurrent non controlled diseases including active infections, symptomatic congestive cardiac insufficiency, unstable chest angina, cardiac arrhythmia and psychiatric diseases that imply the incompetence of the individual. 11. Patients with malignant diseases in the previous 5 years, except skin cancer (not melanoma). 12. Patients that are receiving systemic corticosteroids. 13. Patients with known HIV, B and C hepatitis.

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Lung Cancer Non-small Cell Lung Cancer

Intervention(s)

For each group, the treatment will begin between 28 and 56 days after oncospecific treatment. Stage I Study group (Vaccine): Patients will be administered a total of 15 vaccines. The first 5 vaccines will be administered at 14 day intervals, and the other 10 every month until reaching one year immunization. Each vaccine will contain 1 ml of the vaccine preparation, at a 2 mg/ ml concentration of the 1E10 MAb. The total dose will be subdivided into 4 equal subdoses, administering (0.25 ml) at each inoculation site. The 1E10 anti-idiotype vaccine will be intradermally injected. The potential immunization sites are: the deltoid region, anterior to the forearms and anterior thighs and back of legs. Control group: Placebo. Scheme identical to the study group.

Primary Outcome(s)

Survival. Measuring time: 12 months.

Secondary Outcome(s)

Progression free survival (PFS), Anti-tumoral response, Humoral and Cellular response and toxicity. Measuring time: 12 months.

Secondary ID(s)

IIC RD-EC080

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable