Status:
UNKNOWN
Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
Lead Sponsor:
Alaunos Therapeutics
Conditions:
Malignancy
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide ...
Eligibility Criteria
Inclusion
- 18 years old or greater
- Malignancy scheduled to receive etoposide and carboplatin therapy
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
- Adequate bone marrow, liver, renal function and coagulation status
- Informed consent
- Agree to use birth control through 28 days of last treatment dose
- Pregnancy test for women of child-bearing potential
- No available standard therapy
Exclusion
- Allergy to the the study treatment drugs
- Unstable current medical condition
- Presence or history of injury to the urinary tract
- Active infection
- Major surgery within 4 weeks prior to treatment
- Minor surgery within 2 weeks prior to treatment
- Current acute steroid therapy or taper
- Currently pregnant or nursing
- Substance abuse or condition that may interfere with participation
- Received other investigational drugs within 30 days
- Within 4 weeks of their last chemotherapy
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01242072
Start Date
November 1 2010
End Date
December 1 2012
Last Update
July 18 2012
Active Locations (4)
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1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
Horizon Oncology Research
Lafayette, Indiana, United States, 47905
3
Medical Consultants, PC
Muncie, Indiana, United States, 47303
4
Washington University
St Louis, Missouri, United States, 63110