Leukemia Clinical Trial
Official title:
A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
Verified date | October 2003 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Kimmel Cancer Center (KCC) |
United States,
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