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

Sponsor

Alaunos Therapeutics (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01242072

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignancy Cancer Non Small Cell Lung Cancer Small Cell Lung Cancer Testicular Cancer Thymoma Ovarian Cancer Osteosarcoma	Drug: palifosfamide-tris	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PaCE

Palifosfamide, Carboplatin and Etoposide

Drug: palifosfamide-tris

Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles

Outcome Measures

Primary Outcome Measures

Assess the safety profile [21 Days]
Adverse events, vital signs, physical examination, laboratory data and concomitant medications

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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