Status:
COMPLETED
Study to Investigate the Therapeutic Role of RNA Fragments in Platelet Production During Chemotherapy
Lead Sponsor:
Midwestern Regional Medical Center
Conditions:
Thrombocytopenia
Neoplasm
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to measure the therapeutic potential of Escherichia coli (E. coli) and yeast ribosomal Ribonucleic acid (RNA) fragments to maintain the production of platelets in patients...
Detailed Description
Myelosuppressive chemotherapy has the potential to produce life threatening neutropenia, anemia, and thrombocytopenia. All of these conditions compromise therapeutic dosing which impacts survival as w...
Eligibility Criteria
Inclusion
- between the ages of 18 and 80
- currently receiving chemotherapy with a platelet nadir of less than or equal to 80,000
- Eastern Oncology Oncology Group (ECOG) performance status of 0, 1, 2, 3, and 4
- signed informed consent
- willing to take RealBuild and magnesium supplement and undergoing chemotherapy known to induce thrombocytopenia
- willing to stop benzodiazepines
- must be at least 6 hours post therapeutic heparin dose
Exclusion
- life expectancy less than three months
- pregnant women or women of childbearing potential who refuse to use prophylaxis against pregnancy while receiving chemotherapy regimens
- patients know hypersensitive to RNA or its metabolic products
- patients requiring therapeutic heparin or benzodiazepines
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01163110
Start Date
March 1 2004
End Date
June 1 2007
Last Update
November 15 2013
Active Locations (1)
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1
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099