Study of ZIO-201 in Advanced Sarcoma

NCT00439686 | Completed Phase 1

• 1 other identifier: IPM2001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.

Conditions

Advanced Sarcoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1

  DLTs were assessed during the first 21-day cycle to determine the maximum tolerated dose (MTD). A DLT was defined as any of the following: a non-hematologic Grade 3 toxicity that did not resolve to Grade 2 or lower within 72 hours, excluding alopecia any non-hematologic Grade 4 toxicity, excluding alopecia Grade 4 granulocyte and/or platelet toxicity lasting 7 days or longer Grade 3 or higher neutropenia with an unexplained temperature of 38.5°C or higher on 2 or more occasions within 24 hours The MTD was the dose level below the dose at which at least 33% of participants had a DLT.

  Cycle 1 (21 days)

Secondary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of Palifosfamide

  Cycle 1, Days 1 to 3

• Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Palifosfamide

  Cycle 1, Days 1 to 3

Study Arms (2)

Arm 1: Experimental: Phase 1, palifosfamide 590 mg/m².

EXPERIMENTAL

Palifosfamide-lysine 590 mg/m² IV over 15 minutes on Days 1 to 3 of each 21-day cycle (starting dose; escalation stopped after 2 of 4 participants had dose-limiting toxicities)." Intervention: ZIO-201.

Drug: ZIO-201

Phase 2, palifosfamide 413 mg/m².

EXPERIMENTAL

Palifosfamide-lysine 413 mg/m² IV over 15 minutes on Days 1 to 3 of each 21-day cycle. The last 6 participants first received a single dose of palifosfamide-tris 178 mg/m² in a PK sub-study." Intervention: ZIO-201.

Drug: ZIO-201

Interventions

ZIO-201 DRUG

ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months

Also known as: palifosfamide

Arm 1: Experimental: Phase 1, palifosfamide 590 mg/m².; Phase 2, palifosfamide 413 mg/m².

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Metastatic and /or unresectable disease state after previous standard chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (2)

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

MeSH Terms

Interventions

palifosfamide lysine; isophosphamide mustard

Study Officials

• Jonathan Lewis, MD, PhD

  ZIOPHARM Oncology, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential dose-escalation (3+3 design) followed by an expansion phase. Phase 1 participants received palifosfamide-lysine at the starting dose of 590 mg/m² IV on Days 1 to 3 of each 21-day cycle; escalation stopped after 2 of 4 participants had dose-limiting toxicities. Phase 2 participants were then enrolled sequentially at a reduced dose of 413 mg/m² on the same schedule. The last 6 Phase 2 participants first received a single dose of palifosfamide-tris 178 mg/m² in a pharmacokinetic sub-study.

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 21, 2006
• Primary Completion: January 16, 2008
• Study Completion: January 16, 2008
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

US (2)