Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Leukemia
Intervention: amifostine trihydrate (Drug); cytarabine (Drug); idarubicin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Kimmel Cancer Center (KCC) Official(s) and/or principal investigator(s):
Neal Flomenberg, MD, Study Chair, Affiliation: Kimmel Cancer Center (KCC)
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.
Clinical Details
Official title: A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
Study design: Treatment
Detailed description:
OBJECTIVES:
- Determine whether amifostine provides systemic protection against the nonhematologic
side effects of idarubicin (IDR) during induction therapy of acute myeloid leukemia
(AML), allowing the dose of idarubicin to be escalated.
- Determine the maximum tolerated dose of idarubicin when amifostine is used as a
chemotherapy protectant.
- Determine the incidence and severity of dose limiting hypotension in patients receiving
amifostine and the ability to offset this side effect with vasoconstrictive agents.
- Determine whether any additional side effects of amifostine are dose limiting in
patients with AML treated with IDR and cytarabine (ARA-C).
- Monitor the frequency of alopecia, mucositis, diarrhea, and septicemia involving enteric
pathogens in these patients.
- Determine the requirement for intravenous hyperalimentation in patients receiving
amifostine, IDR, and ARA-C.
OUTLINE: This is a dose escalation study of idarubicin (IDR).
Patients receive amifostine IV over 15 minutes, followed 15-30 minutes later by chemotherapy.
Idarubicin IV is administered over 15 minutes on days 1-3. Cytarabine is administered by
continuous infusion on days 1-7. Patients may receive 1 additional course of treatment, if
necessary.
Cohorts of 3-6 patients each are treated at each dose level of idarubicin. Dose escalation is
discontinued when 2 or more patients experience dose limiting toxicity.
Patients are followed at 3 months.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 1998
Last updated: June 17, 2008
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