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A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer

This study has been completed.
Information provided by:
Ziopharm Identifier:
First received: January 10, 2007
Last updated: September 16, 2009
Last verified: September 2009
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced cancer.

Condition Intervention Phase
Advanced Cancer
Drug: ZIO-201
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer

Resource links provided by NLM:

Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • toxicities [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 months ]

Estimated Enrollment: 30
Study Start Date: February 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Drug: ZIO-201
ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic and /or unresectable disease state after previous standard chemotherapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00421135

United States, California
Santa Monica, California, United States
United States, Michigan
Detroit, Michigan, United States
Sponsors and Collaborators
Study Director: Jonathan Lewis, MD, PhD ZIOPHARM Oncology, Inc
  More Information

Responsible Party: Jonathan Lewis, MD PhD Chief Medical Officer, ZIOPHARM Oncology, Inc Identifier: NCT00421135     History of Changes
Other Study ID Numbers: IPM1001
Study First Received: January 10, 2007
Last Updated: September 16, 2009

Additional relevant MeSH terms:
Isophosphamide mustard
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 25, 2017