NCT00003268

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in treating patients with newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

August 2, 2013

Status Verified

October 1, 2003

First QC Date

November 1, 1999

Last Update Submit

August 1, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganLeukemia

Keywords

untreated adult acute myeloid leukemiaadult acute monoblastic leukemia and acute monocytic leukemia (M5)adult acute erythroid leukemia (M6)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute myelomonocytic leukemia (M4)adult acute megakaryoblastic leukemia (M7)drug/agent toxicity by tissue/organadult acute minimally differentiated myeloid leukemia (M0)

Interventions

amifostine trihydrateDRUG
cytarabineDRUG
idarubicinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Newly diagnosed acute myeloid leukemia (AML) * M0-M2, M4-M7 * Histologically proven by bone marrow aspirate and biopsy (requirement may be waived for patients with overt leukemia in the peripheral blood) * M3 (acute promyelocytic leukemia) patients excluded unless already treated with trans retinoic acid * Evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Not specified Hepatic: * SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * Ejection fraction at least 50% * Must be able to stop taking antihypertensive medication 24 hours prior to cytarabine administration Other: * No preexisting severe organ dysfunction * No history of underlying medical or psychiatric illness that may impair the patient's ability to participate in the study * Not pregnant or nursing * Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior cytotoxic therapy for AML * No prior amifostine * At least 1 month since chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 1 month since radiotherapy Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLeukemiaLeukemia, Monocytic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Megakaryoblastic, Acute

Interventions

AmifostineCytarabineIdarubicin

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Neal Flomenberg, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1998

Study Completion

December 1, 2003

Last Updated

August 2, 2013

Record last verified: 2003-10

Locations

US(1)