Amifostine & High-Dose Combination Chemotherapy in Treating Patients With Acute ML or CML

Withdrawn before enrolling · Phase 2

Conditions studied: Drug/Agent Toxicity by Tissue/Organ, Leukemia, Myelodysplastic Syndromes, Neutropenia

In brief

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.

Key facts

Study ID

NCT00003407

Run by

Rush University Medical Center

People needed

0

Starts

2001-02-13

Expected to finish

2004-04-07

Last updated by the study team

2023-02-02

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

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
• 20% 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

Where it is running

• Cook County Hospital — Chicago, Illinois, United States
• Rush Cancer Institute — Chicago, Illinois, United States
• Angelo P. Creticos, M.D. Cancer Center — Chicago, Illinois, United States
• Rush-Riverside Cancer Center — Kankakee, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.