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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 Arsenic Trioxide Plus Ascorbic Acid in Patients With Recurrent or Refractory Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	Over 18	NCI	SCCC-20010 SCCC-NCI-43, NCI-43, NCT00006021, 43

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug.

Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.

Eligibility:

Eligibility criteria include the following:

• At least 19 years old
• At least 2 weeks since chemotherapy
• 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 infusions of arsenic trioxide and vitamin C 5 days a week for 5 weeks. Treatment may be repeated every 7 weeks for up to six courses. Patients will receive follow-up evaluations once a month for up to 5 years.

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

University of Miami Sylvester Comprehensive Cancer Center - Miami

Kelvin Lee, MD, Protocol chair		Ph: 305-243-6636

Registry Information
Official Title		Phase I/II Trial of Arsenic Trioxide (As2O3) with Ascorbic Acid in the Treatment of Relapsed/Refractory Multiple Myeloma
Trial Start Date		2000-06-01
Registered in ClinicalTrials.gov		NCT00006021
Date Submitted to PDQ		2000-05-25
Information Last Verified		2006-04-27

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