Sirolimus in Treating Patients With Angiomyolipoma of the Kidney

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00126672

First received: August 2, 2005

Last updated: February 1, 2010

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 2, 2005

Last Updated Date

February 1, 2010

Start Date ^ICMJE

June 2005

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective response as assessed by RECIST criteria [ Designated as safety issue: No ]
Toxicity as measured by NCI CTC [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00126672 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Nonmalignant Neoplasm

Intervention ^ICMJE

Drug: sirolimus

Study Arm (s)

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00126672

Other Study ID Numbers ^ICMJE

CDR0000440080, DFCI-04298, WYETH-C-0468H1-101899

Has Data Monitoring Committee

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

Information Provided By

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

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