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Sirolimus in Treating Patients With Angiomyolipoma of the Kidney

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ClinicalTrials.gov Identifier: NCT00126672
Recruitment Status : Unknown
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 4, 2005
Last Update Posted : February 2, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 2, 2005
First Posted Date  ICMJE August 4, 2005
Last Update Posted Date February 2, 2010
Study Start Date  ICMJE June 2005
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2006)
  • Objective response as assessed by RECIST criteria
  • Toxicity as measured by NCI CTC
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sirolimus in Treating Patients With Angiomyolipoma of the Kidney
Official Title  ICMJE A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with angiomyolipoma of the kidney.

Detailed Description

OBJECTIVES:

Primary

  • Determine the efficacy of sirolimus, in terms of objective response rate, in patients with angiomyolipoma of the kidney secondary to tuberous sclerosis (TSC) or lymphangioleiomyomatosis (LAM).
  • Determine the toxicity of this drug in these patients.

Secondary

  • Determine changes in other TSC lesions (e.g., tubers, subependymal giant cell astrocytomas, facial angiofibromas, or kidney cysts) in patients with TSC treated with this drug.
  • Determine changes in pulmonary disease in patients with LAM treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sirolimus once daily for 12 months in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed at 6 months and 1 year.

PROJECTED ACCRUAL: A total of 13-35 patients will be accrued for this study within 3-30 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nonmalignant Neoplasm
Intervention  ICMJE Drug: sirolimus
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2008)
36
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of angiomyolipoma of the kidney secondary to tuberous sclerosis (TSC) or lymphangioleiomyomatosis (LAM)*

    • Tumor ≥ 2 cm by MRI NOTE: *Diagnosis of LAM by chest CT scan
  • No angiomyolipoma-related bleeding or impending bleed
  • No evidence of severe LAM, defined as dependence on continuous oxygen
  • Untreated renal cell carcinoma

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Hematocrit > 27%
  • ANC > 1,500
  • Platelet count > 100,000

Hepatic

  • SGOT and SGPT < 2 times normal
  • Bilirubin < 2 times normal
  • Alkaline phosphatase < 2 times normal

Renal

  • eGFR 30 or higher
  • No evidence of accelerating renal dysfunction
  • No acute renal failure

Cardiovascular

  • No history of coronary artery disease

Pulmonary

  • See Disease Characteristics

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No unstable seizures, defined as a recent change in seizure pattern or change in antiepileptic drug regimen
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational agents
  • More than 6 months since prior vascular embolization therapy for treatment of kidney angiomyolipomas
  • No concurrent chronic use of diltiazem, ketoconazole, or rifampin
  • No other concurrent investigational agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00126672
Other Study ID Numbers  ICMJE CDR0000440080
DFCI-04298
WYETH-C-0468H1-101899
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sandra Dabora, Dana-Farber/Brigham and Women's Cancer Center
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Sandra Dabora, MD, PhD Dana-Farber/Brigham and Women's Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP