We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421135
First Posted: January 11, 2007
Last Update Posted: September 17, 2009
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.
Information provided by:
Ziopharm
  Purpose
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: 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

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
ZIO-201
Drug: ZIO-201
ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: January 10, 2007
First Posted: January 11, 2007
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