Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase I/II Study of Obatoclax Mesylate and Topotecan Hydrochloride in Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	NCI	MSKCC-07082 07-082, 7937, NCT00521144

Trial Description

Purpose:

Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with topotecan may help kill more tumor cells.

This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when given together with topotecan and to see how well they work in treating patients with relapsed or refractory small cell lung cancer or advanced solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No leptomeningeal metastases
• At least 4 weeks since 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 3-hour infusion of obatoclax mesylate on day 1 or days 1 and 3. They will also receive an infusion of topotecan on days 1-5. Treatment may repeat every 3 weeks for as long as benefit is shown.

Some patients will undergo tumor tissue sample collection at the beginning of the study for laboratory studies.

After finishing treatment, patients will be evaluated for 6 weeks.

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

Lee Krug, MD, Principal investigator		Ph: 212-639-8420; 800-525-2225
Naiyer Rizvi, MD, Principal investigator		Ph: 212-639-3204; 800-525-2225

U.S.A.
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Lee Krug, MD	Ph:  212-639-8420 800-525-2225

Registry Information
Official Title		Phase I/II Study of Obatoclax Mesylate (GX15-070MS), a bcl-2 Antagonist, Plus Topotecan in Relapsed Small Cell Lung Carcinoma
Trial Start Date		2007-08-07
Trial Completion Date		2011-08-08 (estimated)
Registered in ClinicalTrials.gov		NCT00521144
Date Submitted to PDQ		2007-08-07
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA08748, 69856