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

This study is ongoing, but not recruiting participants.
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
  Purpose

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 Intervention Phase
Malignancy
Cancer
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Testicular Cancer
Thymoma
Ovarian Cancer
Osteosarcoma
Drug: palifosfamide-tris
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Assess the safety profile [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, physical examination, laboratory data and concomitant medications


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242072

Locations
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Horizon Oncology Research
Lafayette, Indiana, United States, 47905
Medical Consultants, PC
Muncie, Indiana, United States, 47303
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Ziopharm
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT01242072     History of Changes
Other Study ID Numbers: IPM1004
Study First Received: November 12, 2010
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ziopharm:
malignancy
etoposide and carboplatin
non small cell lung cancer
small cell lung cancer
testicular cancer
thymoma
ovarian cancer
osteosarcoma

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Osteosarcoma
Ovarian Neoplasms
Testicular Neoplasms
Thymoma
Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Genital Neoplasms, Male
Genital Diseases, Male

ClinicalTrials.gov processed this record on April 17, 2014