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

Primary Purpose

Malignancy, Cancer, Non Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
palifosfamide-tris
Sponsored by
Alaunos Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignancy focused on measuring malignancy, etoposide and carboplatin, non small cell lung cancer, small cell lung cancer, testicular cancer, thymoma, ovarian cancer, osteosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Indiana University Simon Cancer Center
  • Horizon Oncology Research
  • Medical Consultants, PC
  • Washington University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PaCE

Arm Description

Palifosfamide, Carboplatin and Etoposide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Assess early signs of efficacy
To assess early signs of efficacy using this investigational combination in this patient population

Full Information

First Posted
November 12, 2010
Last Updated
July 17, 2012
Sponsor
Alaunos Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01242072
Brief Title
Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alaunos Therapeutics

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma
Keywords
malignancy, etoposide and carboplatin, non small cell lung cancer, small cell lung cancer, testicular cancer, thymoma, ovarian cancer, osteosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PaCE
Arm Type
Experimental
Arm Description
Palifosfamide, Carboplatin and Etoposide
Intervention Type
Drug
Intervention Name(s)
palifosfamide-tris
Intervention Description
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
Primary Outcome Measure Information:
Title
Assess the safety profile
Description
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
Determine the maximum tolerated dose
Description
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.
Time Frame
Up to 21 days
Title
Assess early signs of efficacy
Description
To assess early signs of efficacy using this investigational combination in this patient population
Time Frame
duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Horizon Oncology Research
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Medical Consultants, PC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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

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