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RAD001(Everolimus) in Treating Patients With Myelodysplastic Syndromes

NCT00809185 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-03-07

Study results available
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Summary

RATIONALE: RAD001(Everolimus) may stop the growth of cancer cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well RAD001(everolimus) works in treating patients with myelodysplastic syndromes.

Conditions

Interventions

DRUG

everolimus

Patients will receive monotherapy with RAD001(everolimus)for 21 days within the 28 day cycle.

OTHER

laboratory biomarker analysis

Laboratory correlates (cytotoxic t cell populations, S6K1 levels, GSTT-1 mutations, and the presence or absence of HLA-DR15) will be assessed to see if any of these correlates correspond to response.

PROCEDURE

Bone marrow aspirate/biopsy

Bone marrow aspirate and biopsy with cytogenetics should be obtained within 4 weeks prior to starting drug and at week 33. A bone marrow aspirate and biopsy should also be obtained for patients going off study prior to week 33 (including cytogenetics). The percentage of blasts on the aspirate should be used to determine the IPSS score.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Anjali Advani, MD · Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809185 on ClinicalTrials.gov