A Phase II Trial of Tamoxifen and Bortezomib in Patients With Recurrent High-Grade Gliomas
Protocol # 05-C-0137
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the study outline?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
This trial is important given the minimal-to-modest activity of Tamoxifen and bortezomib in patients with recurrent gliomas, their spectrum of non-overlapping toxicities, and the marked synergistic glioma cell killing of the combination of drugs in our pre-clinical screens.
Who is eligible for this trial? (PDQ)
- Age 18 and over
- Histologically confirmed malignant glioma, including any of the following:
- Glioblastoma multiforme and its variants (e.g., gliosarcoma)
- Anaplastic glioma, including any of the following types:
- Anaplastic astrocytoma; anaplastic oligodendroglioma; anaplastic mixed oligoastrocytoma; malignant astrocytoma or glioma not otherwise specified
- Must have failed prior radiotherapy
- Evidence of tumor progression by MRI or CT scan while on a steroid dosage that has been stable for ≥ 5 days
- Patients who have undergone prior surgical resection of recurrent or progressive tumor must have subsequent residual disease
- SGOT < 2 times upper limit of normal (ULN); bilirubin < 2 times ULN; creatinine < 1.5 mg/dL
- No tumor progression during prior treatment with Tamoxifen; no coronary artery disease; no congestive heart failure; no arrhythmia requiring medication; no other significant active cardiac disease; no hepatic disease
- No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- Patients must not be on an enzyme-inducing anti-epileptic drug
What types of drugs or therapies are being used?
- Tamoxifen (Nolvadex) 20mg tablets
- Bortezomib (Velcade, PS 431)
What is the study outline? (PDQ)
- Patients receive oral Tamoxifen twice daily on days 1-42 and Bortezomib IV on days 3, 6, 10, 13, 24, 27, 31, and 34
- Treatment repeats every 42 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
What is the frequency and duration of the visits?
Patients will return to the NIH on days 3, 6, 10, 13, 24, 27, 31, and 34 of each 6-week cycle to receive Bortezomib IV. In addition, patients will return to the NIH approximately every 42 days prior to initiating the next cycle of treatment.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Howard A. Fine is currently chief of the Neuro-Oncology Branch at NCI's Center for Cancer Research, and of the National Institute of Neurologic Disorders and Stroke. He received his B.A. from the University of Pennsylvania, Philadelphia, and his M.D. from Mount Sinai School of Medicine, New York. Dr. Fine completed both his internship and his residency in internal medicine at the Hospital of The University of Pennsylvania. Three years later he completed his fellowship in medical oncology at Harvard Medical School's Dana-Farber Cancer Institute, Boston, Mass. Before joining the NIH in 2000, Dr. Fine was both director of the Neuro-Oncology Disease Center at the Dana-Farber Cancer Institute, and of the Neuro-Oncology Program at the Harvard Cancer Center. This NCI senior investigator serves on several committees, including the Brain Tumor Program Review Group and the American Joint Committee on Cancer. Dr. Fine also serves on the editorial boards of several journals, including the Journal of Clinical Oncology, Neuro-Oncology, and The Oncologist. He has received several distinguished awards, including the Dana-Farber Harvard Cancer Center's Clinical Investigator Award in 1999, the Emil Frei III Clinical Investigator Award in 1993, and the Brain Tumor Society Research Award in 1992. His research interests include tumor angiogenesis, therapeutic gene transfer, and neural stem cell biology.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
NCI Neuro-Oncology
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Howard A. Fine, M.D.
Principal Investigator
Phone: (301) 402-6298
Referrals:
Charisse Garcia, R.N.
Research Nurse
Phone: 301-402-6298
Fax: 301-480-2246
Toll free: 866-251-9686
garciacr@mail.nih.gov
Julie Peretti, R.N.
Research Nurse
Phone: 301-402-6298
Fax: 301-480-2246
Toll free: 866-251-9686
jperetti@mail.nih.gov
Tracy Cropper, R.N.
Research Nurse
Phone: 301-496-8250
Fax: 301-480-2246
Toll free: 866-251-9686
tcropper@mail.nih.gov
Where can additional information be found?
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