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A Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Patients With Refractory or Relapsed Acute Myeloid Leukemia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

A Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Patients With Refractory or Relapsed Acute Myeloid Leukemia


Inclusion Criteria:



- Patients with primary refractory AML (that is no prior remission). Patients who have
greater than 10% AML blasts in the bone marrow or blood upon recovery from two cycles
of standard cytarabine- and anthracycline-based induction chemotherapy are eligible.
Patients who have received etoposide and/or 6-thioguanine during remission induction
will be eligible.

- Patients with relapsed AML. Patients must have had a documented remission lasting >
30 days at some point during their prior therapy. Their current relapse must be
untreated. Relapse is defined as the presence of greater than 10% AML blasts in the
bone marrow or blood after having had a documented remission.

- Patients who have received a high-dose cytarabine containing regimen (>2 g/m2/dose)
within 3 months prior to registration on this protocol are not eligible.

- No active CNS involvement. A lumbar puncture prior to treatment is not required and
should not be performed in the absence of significant CNS symptoms or signs.

- Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn
child to significant risks. Women and men of reproductive potential should agree to
use an effective means of birth control.

Exclusion Criteria:

Although NOT considered formal Exclusion Criteria, study physicians are strongly
encouraged as part of this decision-making process to recognize that the following may
increase the risks to a subject entering this protocol:

- Other serious illnesses which would limit survival to <2 years, or a psychiatric
condition which would prevent compliance with treatment or informed consent.

- Performance Status > 2.

- Uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or
infection, which in the opinion of the treating physician, would make this protocol
treatment unreasonably hazardous for the patient.

- Patients with a "currently active" second malignancy other than non-melanoma skin
cancers. Patients are not considered to have a "currently active" malignancy if they
have completed therapy and considered by their physician to be at less than 30% risk
of relapse within one year.

- Patients who have received any investigational agent within the prior 4 weeks.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission rate

Outcome Time Frame:

5 weeks

Safety Issue:

No

Principal Investigator

Raymond Hohl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa

Authority:

United States: Food and Drug Administration

Study ID:

200104050

NCT ID:

NCT00583102

Start Date:

June 2001

Completion Date:

June 2021

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • AML
  • Lovastatin
  • Cytarabine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009