Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT00003268
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1998-01-31
2003-12-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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amifostine trihydrate
cytarabine
idarubicin
Eligibility Criteria
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Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Principal Investigators
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Neal Flomenberg, MD
Role: STUDY_CHAIR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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CDR0000066164
Identifier Type: REGISTRY
Identifier Source: secondary_id
ALZA-97-040-ii
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1395
Identifier Type: -
Identifier Source: secondary_id
TJUH-980407
Identifier Type: -
Identifier Source: org_study_id