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Sponsored by: |
GammaCan |
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Information provided by: | GammaCan |
ClinicalTrials.gov Identifier: | NCT00294476 |
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.
Condition | Intervention | Phase |
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Cancer of Colon Malignant Melanoma Urologic Cancer |
Drug: IVIG Procedure: Biological Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | July 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Oncology institute, Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel | |
Contact: Alberto Gabison, M.D. 972-2-6555036 | |
Contact: Rama Sapir, M.Sc. 972-2-6555727 | |
Principal Investigator: Alberto Gabison, M.D. | |
Israel, Ramat Gan | |
Oncology Institute, Sheba Medical Center | Recruiting |
Tel Hashomer, Ramat Gan, Israel, 52621 | |
Contact: Dan Aderka 972-3-5305259 | |
Contact: Dov Barak, R.N. 972-3-5305201 | |
Principal Investigator: Dan Aderka, M.D | |
Ella Institute, Oncology institute, Sheba Medical Center | Recruiting |
Tel Hashomer, Ramat Gan, Israel, 52621 | |
Contact: Jacob Schachter, M.D 972-3-5302243 | |
Contact: Dov Barak, R.N. 972-3-5305201 | |
Principal Investigator: Jacob Schachter, M.D. |
Principal Investigator: | Dan Aderka, M.D. | Oncology institute, Sheba Madical Center |
Study ID Numbers: | GCan-01 |
Study First Received: | February 19, 2006 |
Last Updated: | October 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00294476 |
Health Authority: | Israel: Ministry of Health |
IVIg Cancer Melanoma |
Genital Neoplasms, Male Prostatic Diseases Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Melanoma Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neoplasm Metastasis Neuroepithelioma Immunoglobulins Digestive System Neoplasms Intestinal Diseases |
Genital Diseases, Male Intestinal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Antibodies Digestive System Diseases Immunoglobulins, Intravenous Gastrointestinal Neoplasms Nevus Colonic Neoplasms Prostatic Neoplasms Colorectal Neoplasms Urinary tract neoplasm |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Immunologic Factors |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Nevi and Melanomas Pharmacologic Actions |