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

Phase 1

• Conditions: Malignancy; Cancer; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Testicular Cancer; Thymoma; Ovarian Cancer; Osteosarcoma
• Interventions: Drug: palifosfamide-tris

• Registration Number: NCT01242072
• Lead Sponsor: Alaunos Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PaCE	palifosfamide-tris	Palifosfamide, Carboplatin and Etoposide

Primary Outcome Measures

Name	Time	Method
Assess the safety profile	21 Days	Adverse events, vital signs, physical examination, laboratory data and concomitant medications

Secondary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose	Up to 21 days	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.
Assess early signs of efficacy	duration of study	To assess early signs of efficacy using this investigational combination in this patient population

Trial Locations

Locations (4)

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Medical Consultants, PC; 🇺🇸 Muncie, Indiana, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Horizon Oncology Research; 🇺🇸 Lafayette, Indiana, United States