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

Study Overview
=================
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 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.

Official Title
-----------------
A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice

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

Intervention / Treatment
-----------------
* Drug: palifosfamide-tris


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PaCE<br>Palifosfamide, Carboplatin and Etoposide | Drug: palifosfamide-tris<br>* Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety profile | Adverse events, vital signs, physical examination, laboratory data and concomitant medications | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum tolerated dose | Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level. | Up to 21 days | 
| Assess early signs of efficacy | To assess early signs of efficacy using this investigational combination in this patient population | duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignancy, etoposide and carboplatin, non small cell lung cancer, small cell lung cancer, testicular cancer, thymoma, ovarian cancer, osteosarcoma