Sirolimus in Combination With MEC in High Risk Myeloid Le... | NCT00780104

Studies
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

NCT00780104

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Completed

Last Update Posted

Jul 12, 2019Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Myeloid Leukemias
AML
Leukemia
CML

Interventions

Rapamycin, Mitoxantrone, Etoposide, Cytarabine
Rapamycin + MEC

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Oct 24, 2008

First Submission Date that Met QC Criteria

Oct 24, 2008

First Posted Date

Oct 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2019

Last Update Posted Date

Jul 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rapamycin + MEC	Experimental		Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine Drug: Rapamycin + MEC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapamycin, Mitoxantrone, Etoposide, Cytarabine	Drug	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.

Measure	Description	Time Frame
Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells		Study conclusion

Measure	Description	Time Frame
Safety of the sirolimus + MEC regimen		Study conclusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D000880	Anthraquinones

ID	Term
D020123	Sirolimus
D008942	Mitoxantrone
D005047	Etoposide
D003561	Cytarabine