The purpose of this study is to evaluate the safety and efficacy of IVIG in the treatment of metastatic cancer of the prostate, colon and melanoma.
This study is a one arm, open label, multi-center, phase II study. Its aim is to evaluate the safety and efficacy of IVIG administered as treatment for metastasis solid tumors. IVIG was proven as affecting the growth of tumor metastasis in animals' models. Study population is including male or female, 18 and older, diagnosed as having a primary tumor (colon, melanoma or prostate) with measurable metastasis (according to the RECIST criteria) in soft tissues and/ or tumor markers in prostate cancer, for which there is no better alternate treatment. The patients receive the IVIG calculated as 1g/kg/bodyweight per cycle (defined as every 21 days) until progression disease is noted. All patients are being followed for a period of 6 months after patient's withdrawal.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Ella Institute, Oncology institute, Sheba Medical Center
Tel Litwinsky, Ramat Gan, Israel
RECRUITINGOncology Institute, Sheba Medical Center
Tel Litwinsky, Ramat Gan, Israel
RECRUITINGOncology institute, Shaare Zedek Medical Center
Jerusalem, Israel
RECRUITING1. Tumor response is measured at baseline and evaluated every 3 treatment cycles (9 weeks) by RECIST(CT or MRI measurements), Time to Progression
and Serum tumor markers as appropriate CEA, PSA. Additionally, ECOG performance status is evaluated before each treatment cycle
Secondary efficacy measurements: Overall survival, Karnofsky Performance Status is evaluated at baseline and before each treatment cycle and Quality of life questionnaires is completed and evaluated at baseline and every 3 treatment cycles (9 weeks)
Safety assessments include Adverse events and laboratory values which are measured and evaluated before every treatment cycle
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