NCT00780104

Brief Summary

The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

October 24, 2008

Last Update Submit

July 10, 2019

Conditions

Myeloid LeukemiasAMLLeukemiaCML

Keywords

Advanced myeloid leukemiasAMLLeukemiaRelapsed myeloid leukemiasRefractory myeloid leukemiasMECRapamycinSirolimus

Outcome Measures

Primary Outcomes (1)

  • Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells

    Study conclusion

Secondary Outcomes (1)

  • Safety of the sirolimus + MEC regimen

    Study conclusion

Study Arms (1)

Rapamycin + MEC

EXPERIMENTAL
Drug: Rapamycin, Mitoxantrone, Etoposide, CytarabineDrug: Rapamycin + MEC

Interventions

Rapamycin, Mitoxantrone, Etoposide, CytarabineDRUG

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

Rapamycin + MEC
Rapamycin + MECDRUG

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

Rapamycin + MEC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are \>= 60 years old
  • \>= 18 years of age
  • ECOG performance status of 0, 1
  • Able to consume oral medication
  • Initial laboratory values: creatinine \<= 2.0 mg/dL; total or direct bilirubin \<= 1.5/dL; SGPT(ALT) \<= 3xULN; negative pregnancy test for women with child-bearing potential
  • Ejection fraction of \>= 45%

You may not qualify if:

  • Subjects with FAM B3
  • Must not be receiving chemotherapy (except Hydroxyurea)
  • Not receiving growth factors, except for erythropoietin
  • Subjects with a "currently active" second malignancy other than non-melanoma skin cancers
  • Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia
  • Subjects taking diltiazem
  • Subjects who require HIV protease inhibitors or those with AIDS-related illnesses
  • No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
  • Not pregnant or breastfeeding
  • Uncontrolled infection
  • Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Leukemia, MyeloidLeukemia

Interventions

SirolimusMitoxantroneEtoposideCytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsQuinonesPolycyclic CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesGlycosidesCarbohydratesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

July 1, 2007

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

US(1)