MedTrace Logo

S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

NCT00066794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2015-03-06

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine, 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.

PURPOSE: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia.

Conditions

Interventions

BIOLOGICAL

filgrastim

5 mcg/kg/d IV or SC starting apx day 15

BIOLOGICAL

sargramostim

250 mcg/kg/d IV or SC starting apx day 15

DRUG

cyclosporine

ind: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-74 consol: 6 mg/kg load IV over 2 hrs days 0-2 followed by 16 mg/dg/d continuous IV days 2-50

DRUG

cytarabine

ind: 200 mg/m2/d cont IV days 2-74

DRUG

daunorubicin hydrochloride

ind: 45 mg/m2/d cont IV days 2-74

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Thomas R. Chauncey, MD, PhD · VA Puget Sound Health Care System

  • Cheryl L. Willman, MD · University of New Mexico Cancer Center

  • Marilyn L. Slovak, PhD · City of Hope Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
56 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-02-28
Completion
2010-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00066794 on ClinicalTrials.gov