A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00233909

First Posted: October 6, 2005

Last Update Posted: April 1, 2008

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:

Kanisa Pharmaceuticals

Purpose

Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia, Myeloid	Drug: Zosuquidar Drug: gemtuzumab ozogamicin	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Resource links provided by NLM:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Gemtuzumab ozogamicin

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia

U.S. FDA Resources

Further study details as provided by Kanisa Pharmaceuticals:


Estimated Enrollment:	55
Study Start Date:	October 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Purpose:

Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.

Phase II: Determine the complete remission rate (CR+CRp)

Eligibility

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:

Morphologic evidence of acute myeloid leukemia in first relapse.
Phase I: 18 years or older, Phase II: 50 years or older

Exclusion Criteria:

Prior treatment with zosuquidar
Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
History of stem cell transplant

Contacts and Locations

No Contacts or Locations Provided

More Information


ClinicalTrials.gov Identifier:	NCT00233909 History of Changes
Other Study ID Numbers:	KAN-979-02
First Submitted:	October 4, 2005
First Posted:	October 6, 2005
Last Update Posted:	April 1, 2008
Last Verified:	March 2008

Keywords provided by Kanisa Pharmaceuticals:


Leukemia, Myeloid Relapse Chemotherapy Zosuquidar gemtuzumab ozogamicin (GO)

Additional relevant MeSH terms:


Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type	Neoplasms Gemtuzumab Antineoplastic Agents

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