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Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML

Information source: University of Iowa
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: Lovastatin and Cytarabine (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of Iowa

Official(s) and/or principal investigator(s):
Raymond Hohl, MD, Principal Investigator, Affiliation: University of Iowa

Overall contact:
Raymond Hohl, MD, Phone: 319-356-8110, Email: raymond-hohl@uiowa.edu

Summary

The purpose of this study is to test the safety and effectiveness of combining a drug known as Lovastatin to the chemotherapy drug cytarabine. Lovastatin is currently used to lower blood cholesterol levels and lab data suggests that it increases the anti-leukemia activity of cytarabine. This research is being done because high doses of cytarabine induce remissions in only about 25% of patients with acute myeloid leukemia.

Clinical Details

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

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

Primary outcome: Complete remission rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Raymond Hohl, MD, Phone: 319-356-8110, Email: raymond-hohl@uiowa.edu

Holden Comprehensive Cancer Center, Iowa City, Iowa 52242, United States; Recruiting
Raymond Hohl, MD, Phone: 319-356-8110, Email: raymond-hohl@uiowa.edu
Karen Parrott, RN, Phone: 319-353-6347, Email: karen-parrott@uiowa.edu
Additional Information

Starting date: June 2001
Last updated: December 20, 2010

Page last updated: November 27, 2014

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