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Brief Title: IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma
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
Study ID: NCT00294476
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ella Institute, Oncology institute, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
Oncology Institute, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
Oncology institute, Shaare Zedek Medical Center, Jerusalem, , Israel
Name: Dan Aderka, M.D.
Affiliation: Oncology institute, Sheba Madical Center
Role: PRINCIPAL_INVESTIGATOR