Overview

This trial is active, not recruiting.

Conditions malignancy, cancer, non small cell lung cancer, small cell lung cancer, testicular cancer, thymoma, ovarian cancer, osteosarcoma
Treatment palifosfamide-tris
Phase phase 1
Sponsor Ziopharm
Start date November 2010
End date December 2012
Trial size 12 participants
Trial identifier NCT01242072, IPM1004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Palifosfamide, Carboplatin and Etoposide
palifosfamide-tris
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles

Primary Outcomes

Measure
Assess the safety profile
time frame: 21 Days

Secondary Outcomes

Measure
Determine the maximum tolerated dose
time frame: Up to 21 days
Assess early signs of efficacy
time frame: duration of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Ziopharm.