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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Drug | |||
| Biological Therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 1. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Aderka, M.D. | Oncology institute, Sheba Madical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ella Institute, Oncology institute, Sheba Medical Center | Recruiting | Tel Litwinsky | Ramat Gan | 52621 | Israel |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D008545 | Melanoma |
| D014571 | Urologic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D001691 | Biological Therapy |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Oncology Institute, Sheba Medical Center | Recruiting | Tel Litwinsky | Ramat Gan | 52621 | Israel |
|
| Oncology institute, Shaare Zedek Medical Center | Recruiting | Jerusalem | Israel |
|
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |