Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00108069 · ClinicalTrials.gov registry record · Phase 2
Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors
A Phase 2 study of Glioma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT00108069 is a Phase 2 study of Glioma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 43 participants, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00108069, a Phase 2 study of Glioma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with tumor growth processes. Laboratory studies show that low doses of bortezomib significantly enhance glioma cell death when used with tamoxifen. Patients 18 years of age and older with glioma whose tumor does not respond to standard medical treatment and who are not taking enzyme-inducing anti-seizure medications such as Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed tomography (CT). MRI and CT scans produce images of the brain that can show if the brain tumor is growing (see below). Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may be extended in some patients who continue to tolerate the drug and show no signs of tumor growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and 34. Treatment may continue as long as the tumor does not grow and the patient does not develop unacceptable side effects. In addition to drug treatment, patients undergo the following tests and procedures: * Periodic routine blood tests. * MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides into the cylindrical scanner. * Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first
Conditions Studied
Interventions
- DRUG Bortezomib
- DRUG Tamoxifen citrate
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2005-04 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00108069
The ClinicalTrials.gov registry entry for NCT00108069 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (79% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 2 interventions - of which Bortezomib is the first listed.
NCT00108069 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00108069 about?
NCT00108069 is a clinical study titled "Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors". This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with tumor growth processe...
What is the current status of trial NCT00108069?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2005-04. Estimated completion is 2013-03.
What conditions does trial NCT00108069 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT00108069?
The interventions under investigation include: Bortezomib (DRUG), Tamoxifen citrate (DRUG).
Who is sponsoring clinical trial NCT00108069?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00108069 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
RECRUITING · Phase 2
-
Pembrolizumab, Olaparib, and Temozolomide for People With Glioma
RECRUITING · Phase 2
-
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
RECRUITING · Phase 2
-
Methimazole in Patients With Progressive Glioblastoma
RECRUITING · Phase 2
-
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
RECRUITING · Phase 2
-
A Study Utilizing Escitalopram in Glioma Patients
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.