- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003268
Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
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.
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Neal Flomenberg, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated adult acute myeloid leukemia
- adult acute erythroid leukemia (M6)
- adult acute megakaryoblastic leukemia (M7)
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
- drug/agent toxicity by tissue/organ
- adult acute monoblastic leukemia and acute monocytic leukemia (M5)
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Drug-Related Side Effects and Adverse Reactions
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Radiation-Protective Agents
- Cytarabine
- Idarubicin
- Amifostine
Other Study ID Numbers
- TJUH-980407
- CDR0000066164 (Registry Identifier: PDQ (Physician Data Query))
- ALZA-97-040-ii
- NCI-V98-1395
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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