Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Supportive care, Treatment	Completed	18 and over	Pharmaceutical / Industry	TJUH-980407 ALZA-97-040-ii, NCI-V98-1395, NCT00003268

Objectives

1. 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.
2. Determine the maximum tolerated dose of idarubicin when amifostine is used as a chemotherapy protectant.
3. Determine the incidence and severity of dose limiting hypotension in patients receiving amifostine and the ability to offset this side effect with vasoconstrictive agents.
4. Determine whether any additional side effects of amifostine are dose limiting in patients with AML treated with IDR and cytarabine (ARA-C).
5. Monitor the frequency of alopecia, mucositis, diarrhea, and septicemia involving enteric pathogens in these patients.
6. Determine the requirement for intravenous hyperalimentation in patients receiving amifostine, IDR, and ARA-C.

Entry 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

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

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

Expected Enrollment

A maximum of 36 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Neal Flomenberg, MD, Protocol chair		Ph: 215-995-9642; 800-533-3669

Registry Information
Official Title		A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia
Trial Start Date		1998-01-09
Registered in ClinicalTrials.gov		NCT00003268
Date Submitted to PDQ		1998-03-16
Information Last Verified		2003-10-22
NCI Grant/Contract Number		P30-CA10815, P30-CA56036

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