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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Ziopharm.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT01242072
First received: November 12, 2010
Last updated: July 17, 2012
Last verified: July 2012

November 12, 2010
July 17, 2012
November 2010
December 2012   (final data collection date for primary outcome measure)
Assess the safety profile [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Assess the safety profile [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Complete list of historical versions of study NCT01242072 on ClinicalTrials.gov Archive Site
  • Determine the maximum tolerated dose [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: duration of study ] [ Designated as safety issue: No ]
    To assess early signs of efficacy using this investigational combination in this patient population
Determine the maximum tolerated dose [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
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.
Not Provided
Not Provided
 
Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignancy
  • Cancer
  • Non Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Testicular Cancer
  • Thymoma
  • Ovarian Cancer
  • Osteosarcoma
Drug: palifosfamide-tris
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
Experimental: PaCE
Palifosfamide, Carboplatin and Etoposide
Intervention: Drug: palifosfamide-tris
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01242072
IPM1004
No
Ziopharm
Ziopharm
Not Provided
Not Provided
Ziopharm
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP