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NCT00971789 · ClinicalTrials.gov registry record · Phase 2
Sirolimus to Treat Cowden Syndrome and Other PTEN Hamartomatous Tumor Syndromes
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00971789: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00971789 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00971789, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Background: People with phosphatase and tensin homolog deleted on chromosome 10 (PTEN) hamartomatous tumor syndromes (PHTS) have a mutation in one of their genes called PTEN that can lead to benign tumors called hamartomas throughout the body. This puts them at increased risk for breast, thyroid and endometrial cancer. People with a PTEN mutation have increased activity of proteins such as protein kinase B (AKT) and mammalian target of rapamycin (mTOR), which may be responsible for tumor growth and their increased risk of these cancers. Experiments show that a drug called sirolimus, which is used to prevent the immune system from rejecting transplanted organs, can inhibit cancer cell growth by blocking the mTOR protein. Objectives: To test the ability of sirolimus to decrease the activity of proteins that are regulated by mTOR in both benign and cancerous tumor tissue. Eligibility: People 18 years of age and older with Cowden syndrome or other PHTS. Design: Sirolimus treatment. Patients take sirolimus once a day in 28-day treatment cycles. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects. Evaluations. Patients come to the clinic for a history and physical examination on day 1 of every treatment cycle, then every month for the first two months off therapy, and then at 6 and 12 months. In addition, they have the following procedures: * Positron emission tomography (PET) scan and neuropsychological testing before starting treatment. * Clinical photography (photographic documentation of skin lesions) before starting treatment. Patients who do not have cancer have repeat photography at 2 and 8 weeks and then, if the lesions shrink or go away while on therapy, again every month for the first 2 months off sirolimus, then at 6 months and 1 year. Patients wh
Interventions
- RADIATION fludeoxyglucose F 18
- DRUG sirolimus
- OTHER Clinical Videography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00971789
The ClinicalTrials.gov registry entry for NCT00971789 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which fludeoxyglucose F 18 is the first listed.
NCT00971789 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00971789 about?
NCT00971789 is a clinical study titled "Sirolimus to Treat Cowden Syndrome and Other PTEN Hamartomatous Tumor Syndromes". Background: People with phosphatase and tensin homolog deleted on chromosome 10 (PTEN) hamartomatous tumor syndromes (PHTS) have a mutation in one of their genes called PTEN that can lead to benign tumors called hamartomas throughout the body. This puts them at increased risk for breast, thyroid an...
What is the current status of trial NCT00971789?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2008-07. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00971789?
The interventions under investigation include: fludeoxyglucose F 18 (RADIATION), sirolimus (DRUG), Clinical Videography (OTHER).
Who is sponsoring clinical trial NCT00971789?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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