Study to Investigate the Therapeutic Role of RNA Fragments in Platelet Production During Chemotherapy
Phase II Dose of Escalation Design to Investigate the Therapeutic Role of RNA Fragments in the Protection of Platelet Production During Chemotherapy
1 other identifier
interventional
32
1 country
1
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 undergoing cytotoxic therapy for cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 13, 2010
CompletedFirst Posted
Study publicly available on registry
July 15, 2010
CompletedNovember 15, 2013
November 1, 2013
3.3 years
July 13, 2010
November 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Determine whether E. coli or yeast ribosomal ribonucleic acid (rRNA) fragments prophylactically prevent the development of thrombocytopenia during chemotherapy.
Time to Platelet recovery after nadir
Secondary Outcomes (1)
Determine whether E. coli or yeast rRNA fragments accelerate the recovery of platelets in patients undergoing chemotherapy.
Time to platelet transfusion 3 weeks after nadir
Interventions
Patient with chemotherapy induced thrombocytopenia takes RNA fragments orally to accelerate time to platelet recovery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Related Publications (1)
Levin RD, Daehler M, Grutsch JF, Hall JL, Gupta D, Lis CG. Dose escalation study of an anti-thrombocytopenic agent in patients with chemotherapy induced thrombocytopenia. BMC Cancer. 2010 Oct 19;10:565. doi: 10.1186/1471-2407-10-565.
PMID: 20955619DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Levin, MD
Midwestern Regional Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
July 13, 2010
First Posted
July 15, 2010
Study Start
March 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
November 15, 2013
Record last verified: 2013-11