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

Alternate Title

Phase I Study of MS-275 and Isotretinoin in Patients With Metastatic, Progressive, Refractory, or Unresectable Solid Tumors or Lymphomas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	JHOC-J0438 6798, NCI-6798, JHOC-04060103, NCT00098891

Trial Description

Purpose:

MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may help cancer cells develop into normal cells. MS-275 may increase the effectiveness of isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer. Combining MS-275 with isotretinoin may kill more cancer cells.

Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• No previous MS-275
• More than 4 weeks since biological therapy, chemotherapy, or radiation therapy for cancer
• More than 4 weeks since surgery
• 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 MS-275 by mouth once a week and isotretinoin by mouth twice a day for 3 weeks. Treatment may be repeated every 4 weeks for as long as benefit is shown. Patients will be evaluated once a month.

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Roberto Pili, MD, Protocol chair(Contact information may not be current)		Ph: 410-955-8964

Registry Information
Official Title		A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275 (NSC 706995, IND 61,196), in Combination With 13-Cis-Retinoic Acid in Metastatic Progressive Cancer
Trial Start Date		2004-12-06
Trial Completion Date		2008-03-24
Registered in ClinicalTrials.gov		NCT00098891
Date Submitted to PDQ		2004-10-07
Information Last Verified		2006-09-17
NCI Grant/Contract Number		CA70095, CA06973

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