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
  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:


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
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, see Learn About Clinical Studies.

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 September 30, 2014