Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
NCT ID: NCT01242072
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2010-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PaCE
Palifosfamide, Carboplatin and Etoposide
palifosfamide-tris
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
Interventions
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palifosfamide-tris
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Alaunos Therapeutics
INDUSTRY
Responsible Party
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Locations
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Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Horizon Oncology Research
Lafayette, Indiana, United States
Medical Consultants, PC
Muncie, Indiana, United States
Washington University
St Louis, Missouri, United States
Countries
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Other Identifiers
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IPM1004
Identifier Type: -
Identifier Source: org_study_id