Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies

Status unconfirmed · Phase 1

Conditions studied: Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma

In brief

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 and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.

Key facts

Study ID

NCT01242072

Run by

Alaunos Therapeutics

People needed

12

Starts

2010-11-01

Expected to finish

2012-12-01

Last updated by the study team

2012-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.