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