

Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
Close
Treatment Agent: Temozolomide, radiotherapy, PCV chemotherapy
Synopsis: The purpose of this study is to see if you have a certain kind of tumor, one that is missing part of both chromosomes 1 and 19. These missing parts of chromosomes are called a “tumor marker” as they make the tumor distinct from other kinds of tumors. This tumor marker is called the 1p/19q co-deletion. Tumors with this 1p/19q co-deletion typically have a more favorable outcome than other types of anaplastic glioma. Standard therapy at this point in time is surgery followed by radiation therapy.
Another purpose of this study is to see if patients survive for a longer period of time without the tumor progressing if thy are treated with a combination of radiotherapy with temozolomide chemotherapy as compared to radiotherapy with PCV chemotherapy (procarbazine, CCNU, and vincristine, which are the drugs that are used in this chemotherapy treatment, also known as PCV)
Close
Close
Close
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma
Close
Treatment: Radiation
Synopsis: This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Close
Close
Close
Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM)
Close
Treatment Agent: N/A
Synopsis: The investigational purpose of this study is to screen chemotherapy drugs currently used for the care of recurrent glioblastoma (a form of brain cancer) and to determine the most effective treatment based on results from a chemosensitivity assay. Chemosensitivity drug assay refers to testing a patient's own cancer cells in the laboratory to drugs that are to be used to treat the patient's cancer.
Following surgery, you will be treated either as per chemotherapy agents chosen by the physician or with chemotherapies as suggested by the results of the chemosensitivity testing.
We would like to determine if patients treated with drugs predicted by the chemosensitivity test have better outcomes than patients treated with drugs chosen by the treating physician.
We expect that you will be in this research study for 3 years. This study is designed to follow you for long-term survival as such – your doctor and his/her staff would like to follow your long-term health status for a period of not more than 36 months, by accessing your hospital records.
This study uses sample specimens obtained by the same surgical procedures that patients have to routinely undergo for the treatment of recurrent brain cancer.
You should discuss with the study staff the risks of being in this study, which are the same as the risks of being treated with standard-of-care chemotherapy and radiation. There may be side effects that we cannot predict. You should tell the research staff about all the medications, vitamins and supplements you take and any medical conditions you have. This may help avoid side effects, interactions and other risks.
There may be no direct benefit to you from participating in this study. However, this study may help doctors learn more about your disease and it is hoped that this information will help in the treatment of future patients with conditions like yours. One possible benefit includes prolonged response to treatment. If you decide not to participate in this research, your other choice may include:
• Comfort Care, which includes pain medication and other support. This aims to maintain your comfort and dignity rather than cure disease. Usually this care can be provided at home
Close
1. Men and Women and members of all ethnic groups who are at least 18 years old at the time of enrollment are eligible for this trial;
2. Informed consent obtained and signed;
3. Willing and able to commit to study procedures including long-term follow-up visit(s);
4. Histopathologically confirmed WHO grade IV recurrent glioblastoma (GBM).
5. In all cases, the diagnosis must be confirmed by a pathologist.
6. Recurrent surgically resectable tumor and/or biopsy;
7. Participants who have undergone surgical resection should have received an MRI or a scan after surgery in order to visualize residual tumor. If not, the operative report must be available;
8. Start of radiotherapy, if indicated, must occur at least 2 weeks after surgery and/or biopsy;
9. Estimated survival of at least 3 months;
10. Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value;
11. If indicated radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy.
Close
1. Subjects with newly diagnosed GBM
2. Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. Women of childbearing potential must practice medically approved contraceptive precautions;
3. Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3
4. Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min);
5. Patient unable to follow procedures, visits, examinations described in the study;
6. Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);
Close
Interested in a
Clinical Trial?