Malignant Melanoma Clinical Trial
Official title:
A One Arm, Open Label,Multi - Center Phase II Study to Evaluate the Safety and Efficacy of IVIG in the Treatment of Various Metastatic Solid Tumors for Which There is no Better Alternate Treatment
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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