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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00421135
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : September 17, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced cancer.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: ZIO-201 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer
Study Start Date : February 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single Arm
ZIO-201
Drug: ZIO-201
ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.


Outcome Measures

Primary Outcome Measures :
  1. toxicities [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Metastatic and /or unresectable disease state after previous standard chemotherapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421135


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

Responsible Party: Jonathan Lewis, MD PhD Chief Medical Officer, ZIOPHARM Oncology, Inc
ClinicalTrials.gov Identifier: NCT00421135     History of Changes
Other Study ID Numbers: IPM1001
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Neoplasms
Isophosphamide mustard
Ifosfamide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents