Know Cancer

or
forgot password

A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Leukemia

Thank you

Trial Information

A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Neal Flomenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000066164

NCT ID:

NCT00003268

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107