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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.
Sponsor:
Information provided by:
ZIOPHARM
ClinicalTrials.gov Identifier:
NCT00421135
First received: January 10, 2007
Last updated: September 16, 2009
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by ZIOPHARM:

Primary Outcome Measures:
  • toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

No publications provided

Responsible Party: Jonathan Lewis, MD PhD Chief Medical Officer, ZIOPHARM Oncology, Inc
ClinicalTrials.gov Identifier: NCT00421135     History of Changes
Other Study ID Numbers: IPM1001
Study First Received: January 10, 2007
Last Updated: September 16, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013