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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 High-Dose Calcitriol and Temozolomide in Patients With Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over NCI, Pharmaceutical / Industry NU-05M1 NU-0310-093, SPRI-NU-05M1, NCT00301067

Trial Description

Purpose:

Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.

This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• At least 4 weeks since radiation therapy, chemotherapy, and biological therapy
• No previous temozolomide or dacarbazine
• 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 calcitriol by mouth once in week 1 and week 3. They will also receive temozolomide by mouth for 7 days beginning in weeks 1 and 3. Treatment may repeat every 4 weeks for up to six courses.

After finishing treatment, patients will be evaluated every 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

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Timothy Kuzel, MD, Protocol chair		Ph: 312-695-6180
John Eklund, MD, Protocol co-chair		Ph: 312-695-6180 Email: j-eklund@northwestern.edu

U.S.A.
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu

Registry Information
Official Title		A Phase I/II Study of High-Dose Calcitriol in Combination with Temozolomide for Patients with Metastatic Melanoma
Trial Start Date		2005-11-17
Trial Completion Date		2011-11-30 (estimated)
Registered in ClinicalTrials.gov		NCT00301067
Date Submitted to PDQ		2005-10-20
Information Last Verified		2008-04-20
NCI Grant/Contract Number		CA60553