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Sirolimus in Combination With MEC in High Risk Myeloid Leukemias (UPCC 02407)

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00780104
First received: October 24, 2008
Last updated: September 29, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Myeloid Leukemias
AML
Leukemia
CML
 Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine
Drug: Rapamycin + MEC
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells [ Time Frame: Study conclusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of the sirolimus + MEC regimen [ Time Frame: Study conclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: July 2007
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapamycin + MEC Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine
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.
Drug: Rapamycin + MEC
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780104

Locations
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: Selina Luger, M.D., University of Pennsylvania Abramson Cancer Center
ClinicalTrials.gov Identifier: NCT00780104     History of Changes
Other Study ID Numbers: UPCC 02407
Study First Received: October 24, 2008
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Advanced myeloid leukemias
AML
Leukemia
Relapsed myeloid leukemias
 Refractory myeloid leukemias
MEC
Rapamycin
Sirolimus

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Sirolimus
Everolimus
Etoposide phosphate
Etoposide
Mitoxantrone
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
 Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013