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Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01217125
First Posted: October 8, 2010
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
Roser Torra, Fundacio Puigvert
  Purpose
The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.

Condition Intervention Phase
Angiomyolipoma Drug: Sirolimus Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS

Resource links provided by NLM:


Further study details as provided by Roser Torra, Fundacio Puigvert:

Primary Outcome Measures:
  • Angiomyolipoma volume [ Time Frame: 2 years ]
    Measured by MRI


Secondary Outcome Measures:
  • skin lesions, AML complications, [ Time Frame: 2 years ]
    Evaluate skin lesions Collect event realted to AML


Enrollment: 18
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sirolimus
    plasma levels between 4 and 8
    Other Name: Rapamune
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years

Exclusion Criteria:

Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit<27% Thrombocytopenia (<100.000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l or hypertriglyceridemia fasten(>4.6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217125


Sponsors and Collaborators
Fundacio Puigvert
Ministry of Health, Spain
Investigators
Principal Investigator: Roser Torra, MD,PhD Fundacio Puigvert, Barcelona
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roser Torra, MD, PhD, Fundacio Puigvert
ClinicalTrials.gov Identifier: NCT01217125     History of Changes
Other Study ID Numbers: EudraCT 2007-005978-30
First Submitted: October 6, 2010
First Posted: October 8, 2010
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Roser Torra, Fundacio Puigvert:
tuberousclerosis, angiomyolipoma, rapamycin

Additional relevant MeSH terms:
Sclerosis
Tuberous Sclerosis
Angiomyolipoma
Pathologic Processes
Hamartoma
Neoplasms
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Perivascular Epithelioid Cell Neoplasms
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors