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

Alternate Title

Phase III Randomized Study of Mitoxantrone/Etoposide/Cytarabine (MEC) versus MEC Plus PSC 833 (PSC MEC) in Patients with Recurrent or Refractory Acute Myelogenous Leukemia (AML)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	15 to 70	NCI	E-2995 E2995

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a chemotherapy drug may reduce resistance to the drug, and allow the cancer cells to be killed. It is not known whether receiving chemotherapy with PSC 833 is more effective than chemotherapy without PSC 833 in treating patients with recurrent or refractory acute myeloid leukemia or high risk myelodysplastic syndrome.

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 in treating patients with recurrent or refractory acute myeloid leukemia or high risk myelodysplastic syndrome.

Eligibility:

• 15-70 years old
• No CNS involvement
• 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 be randomized to one of two groups. Patients in group one will receive an infusion of three chemotherapy drugs once a day for 5 days plus a 5-day continuous infusion of PSC 833 beginning 4 hours before the three-drug infusion. Patients in the second group will receive an infusion of three chemotherapy drugs once a day for 5 days. Patients may receive a second course of treatment. Patients will receive follow-up evaluations 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

Eastern Cooperative Oncology Group

Peter Greenberg, MD, Protocol chair		Ph: 650-725-8355; 800-756-9000 Email: peterg@stanford.edu

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