Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia - Full Text View

Sponsor:	Kimmel Cancer Center (KCC)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003268

Purpose

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.

Condition	Intervention	Phase
Drug/Agent Toxicity by Tissue/Organ Leukemia	Drug: amifostine trihydrate Drug: cytarabine Drug: idarubicin	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine hydrochloride Amifostine Idarubicin hydrochloride Idarubicin Cytarabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 1998

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003268

Locations

United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541

Sponsors and Collaborators

Kimmel Cancer Center (KCC)

Investigators

Study Chair:

Neal Flomenberg, MD

Kimmel Cancer Center (KCC)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066164, TJUH-980407, ALZA-97-040-ii, NCI-V98-1395
Study First Received:	November 1, 1999
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00003268 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated adult acute myeloid leukemia
adult acute monoblastic leukemia and acute monocytic leukemia (M5)
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)

adult acute myelomonocytic leukemia (M4)
adult acute megakaryoblastic leukemia (M7)
drug/agent toxicity by tissue/organ
adult acute minimally differentiated myeloid leukemia (M0)

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Radiation-Protective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Amifostine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid

Antibiotics, Antineoplastic
Leukemia, Myeloid, Acute
Protective Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Idarubicin
Therapeutic Uses
Cytarabine

ClinicalTrials.gov processed this record on November 09, 2009