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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Study of Bismuth Bi 213 Monoclonal Antibody M195 and Cytarabine in Patients With Advanced Myeloid Malignancies

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Not specified	NCI	MSKCC-00117 NCI-H01-0071, NCT00014495

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

Phase I/II trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer.

Eligibility:

Eligibility criteria include the following:

• At least 3 weeks since biological therapy, chemotherapy or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive a 5-day continuous infusion of cytarabine. Within 2 weeks, patients will receive an infusion of monoclonal antibody up to four times a day for 4 days. Patients will then receive an injection of filgrastim once a day until blood counts return to normal. Treatment may be repeated for as long as benefit is shown. Patients will be evaluated twice a week for 4 weeks and then once a month for 3 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Joseph Jurcic, MD, Protocol chair		Ph: 212-639-2955; 800-525-2225 Email: jurcicj@mskcc.org

Registry Information
Official Title		Phase I/II Trial Of Sequential Therapy With Cytarabine And Bismuth-213-Labeled HuM195 (Humanized Anti-CD33) In Patients With Advanced Myeloid Malignancies
Trial Start Date		2000-11-14
Trial Completion Date		2010-12-13 (estimated)
Registered in ClinicalTrials.gov		NCT00014495
Date Submitted to PDQ		2001-02-15
Information Last Verified		2008-10-22
NCI Grant/Contract Number		CA33049, CA08748

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