NCT00003407

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2001

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 13, 2001

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2004

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

November 1, 1999

Last Update Submit

January 31, 2023

Conditions

Drug/Agent Toxicity by Tissue/OrganLeukemiaMyelodysplastic SyndromesNeutropenia

Keywords

recurrent adult acute myeloid leukemiablastic phase chronic myelogenous leukemiauntreated adult acute myeloid leukemiarefractory anemia with excess blasts in transformationsecondary acute myeloid leukemiade novo myelodysplastic syndromessecondary myelodysplastic syndromesdrug/agent toxicity by tissue/organneutropenia

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia

    Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

    6 months

Study Arms (1)

Effectiveness of amifostine &high-dose combination chemotherapy in treating patients with AML or CML

EXPERIMENTAL

Treatment of Newly Diagnosed High Risk And Relapsed Acute Myeloid Leukemia and Blastic Crisis Chronic Myelogenous Leukemia With Ethyol and High-Dose Cytarabine + Mitoxantroni, followed by Maintenance Phase Using Low-Dose ARA-C, rhGM-CSF, Pentoxifylline, Ciprofloxacin, and Decadron

Drug: amifostine trihydrateDrug: cytarabineDrug: mitoxantrone hydrochloride

Interventions

amifostine trihydrateDRUG
Effectiveness of amifostine &high-dose combination chemotherapy in treating patients with AML or CML
cytarabineDRUG
Effectiveness of amifostine &high-dose combination chemotherapy in treating patients with AML or CML
mitoxantrone hydrochlorideDRUG
Effectiveness of amifostine &high-dose combination chemotherapy in treating patients with AML or CML

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS: Newly diagnosed high-risk acute myeloid leukemia (AML) defined as AML after myelodysplastic syndrome; refractory anemia with excess blasts in transformation or "AML in evolution" also eligible AML following a chronic myeloproliferative disorder (except chronic myelogenous leukemia).
  • Therapy-related AML or AML following exposure to a known hematopoietic toxin Relapsed AML Age 70 or older OR AML in first relapse defined as
  • AML in first relapse without treatment on protocol AML-9801 Relapsed following standard chemotherapy Previously treated on AML-9701 and relapsed after at least 6 months of remission OR Chronic myelogenous leukemia (CML) in blast crisis defined as
  • % or more blast cells in the bone marrow or peripheral blood Pure lymphoid blastic crisis eligible if resistant to an acute lymphocytic leukemia type treatment regimen or relapsed after initial response to such treatment.
  • PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy
  • Not specified Hematopoietic:
  • Not specified Hepatic: Bilirubin less than 3 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine less than 3 mg/dL Cardiovascular:
  • No overt congestive heart failure or uncontrollable ventricular arrhythmias
  • No uncontrollable hypertension Neurologic: No cerebellar dysfunction
  • Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception.
  • PRIOR CONCURRENT THERAPY: See Disease Characteristics above.

You may not qualify if:

  • Not identified by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cook County Hospital

Chicago, Illinois, 60612-9985, United States

Location

Rush Cancer Institute

Chicago, Illinois, 60612, United States

Location

Angelo P. Creticos, M.D. Cancer Center

Chicago, Illinois, 60657, United States

Location

Rush-Riverside Cancer Center

Kankakee, Illinois, 60901, United States

Location

Related Links

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLeukemiaMyelodysplastic SyndromesNeutropeniaLeukemia, Myeloid, AcuteBlast Crisis

Interventions

AmifostineCytarabineMitoxantrone

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsQuinonesPolycyclic Compounds

Study Officials

  • Philip D. Bonomi, MD

    Rush University Medical Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 27, 2004

Study Start

February 13, 2001

Primary Completion

April 7, 2004

Study Completion

April 7, 2004

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

US(4)