Trials / Unknown
UnknownNCT00294476
IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- GammaCan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IVIG | |
| PROCEDURE | Biological Therapy |
Timeline
- Start date
- 2005-07-01
- First posted
- 2006-02-22
- Last updated
- 2006-10-12
Locations
3 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT00294476. Inclusion in this directory is not an endorsement.