MedTrace Logo

S9918 PSC 833, Daunorubicin, and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00004217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-03-06

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by making them more sensitive to the drugs.

PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia.

Conditions

Interventions

BIOLOGICAL

filgrastim

5 μg/kg/day IV or SC

BIOLOGICAL

sargramostim

5 μg/kg/day IV or SC starting d 15

DRUG

cytarabine

Ara-C continuous IV: Hours 2.5 - 170.5 before PSC-833

DRUG

daunorubicin hydrochloride

continuous IV: Hours 2 - 74 before PSC-833

DRUG

valspodar

2 mg/kg load IV over 2 hrs (loading); 10 mg/kg/day Continuous hours 0 - 96

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

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
2000-02-29
Primary Completion
2001-05-31
Completion
2006-03-31

Countries

  • United States
  • Canada

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 NCT00004217 on ClinicalTrials.gov