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Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of everolimus.

- Determine the toxicity of this regimen.

Secondary

- Assess the activation of PI3K/AKT and mTORC 1 in leukemic blasts.

- Evaluate the pharmacokinetics of everolimus at different concentrations.

OUTLINE: This is a multicenter study.

Patients receive primary induction therapy comprising daunorubicin hydrochloride IV on days
1-3, cytarabine IV over 24 hours on day 1, and oral everolimus on days 1 and 7. Patients
with more than 5% blasts on day 15 receive a second induction course comprising daunorubicin
hydrochloride IV on days 17 and 18 and cytarabine IV twice daily on days 17-20.

After completion of study therapy, patients are followed for 3 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

- Diagnosis of de novo or secondary acute myeloid leukemia meeting the following
criterion:

- Relapse > 1 year after obtaining complete remission (any prior treatment
allowed)

Exclusion criteria:

- Philadelphia chromosome-positive disease in blast crisis

- FAB M3, M6, or M7 disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Life expectancy ≥ 4 weeks

- Transaminases ≤ 5 times normal

- Creatinine ≤ 2 times normal

- Bilirubin ≤ 3 times normal (except if visceral involvement present)

- Alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients of must use effective contraception during and for ≥ 28 days after
completion of study therapy

Exclusion criteria:

- FEV1 < 30%

- Active uncontrolled or viral pulmonary infection

- Serious psychiatric disorders not related to leukemia or any condition that would
prohibit comprehension of the study

- HIV-positive

- Other concurrent malignancy except noninvasive skin cancer or carcinoma in situ

- Patients who are incarcerated or under supervision or trusteeship

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- See Disease Characteristics

Exclusion criteria:

- Prior experimental medication within the past 4 weeks

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of everolimus

Safety Issue:

Yes

Principal Investigator

Sophie Park, MD

Investigator Affiliation:

Institut de Recherches sur les Leucemies et les Maladies du Sang

Authority:

Unspecified

Study ID:

CDR0000564068

NCT ID:

NCT00544999

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute monocytic leukemia (M5b)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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