IMMUNEPOTENT CRP (bovine dialyzable leukocyte extract) adjuvant immunotherapy: a phase I study in non-small cell lung cancer patients.
BACKGROUND
IMMUNEPOTENT CRP is a mixture of low molecular weight substances, some of which have been shown to be capable of modifying the immune response. We evaluated the response and adjuvant effect of IMMUNEPOTENT CRP on non-small cell lung cancer (NSCLC) patients in a phase I clinical trial.


METHODS
Twenty-four NSCLC patients were included in the study and divided into two groups. Group 1 received a conventional treatment of 5400 cGy external radiotherapy in 28 fractions and chemotherapy consisting of intravenous cisplatin (40 mg/m(2)) delivered weekly for 6 weeks. Group 2 received the conventional treatment plus IMMUNEPOTENT CRP (5 U) administered daily. We performed clinical evaluation by CT scan and radiography analysis, and determined the quality of life of the patients with the Karnofsky performance scale. A complete blood count (red and white blood cell tests), including flow cytometry analysis, blood work (alkaline phosphatase test) and a delayed-type hypersensitivity (DTH) skin test for PPD, Varidase and Candida were performed.


RESULTS
The administration of IMMUNEPOTENT CRP induced immunomodulatory activity (increasing the total leukocytes and T-lymphocyte subpopulations CD4(+), CD8(+), CD16(+) and CD56(+), and maintaining DHT) and increased the quality of the patients' lives, suggesting immunologic protection against chemotherapeutic side-effects in NSCLC patients.


CONCLUSIONS
Our results suggest the possibility of using IMMUNEPOTENT CRP alongside radiation and chemotherapy for maintaining the immune system and increasing the quality of life of the patients.
Franco-Molina
M A
MA
Laboratorio de Inmunología y Virología, Departamento de Microbiología e Inmunología, Facultad de Ciencias Biológicas de la Universidad Autónoma de Nuevo León, San Nicolás de los Garza, México.
Mendoza-Gamboa
E
E
Zapata-Benavides
P
P
Vera-García
M E
ME
Castillo-Tello
P
P
García de la Fuente
A
A
Mendoza
R D
RD
Garza
R G
RG
Támez-Guerra
R S
RS
Rodríguez-Padilla
C
C
D000328:Adult; D000818:Animals; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D002417:Cattle; D002457:Cell Extracts / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007167:Immunotherapy; D017567:Karnofsky Performance Status; D007963:Leukocytes, Mononuclear / Q000378:metabolism* / Q000473:pathology; D008175:Lung Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011878:Radiotherapy
D002457:Cell Extracts; D002945:Cisplatin