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| Sponsor: | GammaCan |
|---|---|
| Information provided by: | GammaCan |
| ClinicalTrials.gov Identifier: | NCT00294476 |
Purpose
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 |
|---|---|---|
|
Cancer of Colon Malignant Melanoma Urologic Cancer |
Drug: IVIG Procedure: Biological Therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Israel | |
| 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. | |
| 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. | |
| Principal Investigator: | Dan Aderka, M.D. | Oncology institute, Sheba Madical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00294476 History of Changes |
| Other Study ID Numbers: | GCan-01 |
| Study First Received: | February 19, 2006 |
| Last Updated: | October 11, 2006 |
| Health Authority: | Israel: Ministry of Health |
|
IVIg Cancer Melanoma |
|
Colonic Neoplasms Melanoma Prostatic Neoplasms Urologic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Immunoglobulins, Intravenous Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |