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Home > "I" Clinical Trials Conditions > Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas  Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
For Condition: Astrocytoma,Glioma,Oligodendroglioma,Glioblastoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The drug talampanel may inhibit the growth of gliomas by interfering with neurotransmitters in the brain that aid in tumor growth. A glioma is a common type of brain tumor. The purposes of this study are (1) to determine whether talampanel will have any effect on the growth of high-grade gliomas and (2) to investigate the side effects of talampanel when it is administered to patients with recurrent high-grade gliomas. To qualify for this study, participants must be at least 18 years old, have been diagnosed with a recurrent high-grade brain tumor by an MRI or CT scan, and be able to swallow the talampanel tablets. The study will cover patients who are on antiseizure medication and those who are not. Participants will be placed into one of three groups: those taking certain anti-epileptic drugs, those not taking certain anti-epileptic drugs, and those taking valproic acid for seizures. Patients will take capsules three times a day every day for six weeks or one cycle (each six-week period is one cycle). Every three weeks in the first cycle, and every six weeks thereafter, participants will undergo history, physical, and neurological exams, and a head MRI or CT scan. They will undergo routine labwork every three weeks. As long as there are no signs of tumor growth and no serious side effects, patients can continue to take talampanel. Approximately 91 patients will participate in this study. Their participation is expected to last up to one year.
Details: High-grade gliomas represent an important cause of cancer morbidity and mortality in this country. Despite progress in neurosurgical and radio therapeutic techniques, there has been little improvement in the overall prognosis of patients with high-grade gliomas in the last 20 years. Standard chemotherapy is generally ineffective in this disease and thus new targets and agents with novel mechanisms of action are needed. Glutamate is the principle excitatory neurotransmitter in the brain. Membrane-bound flutamate receptors are divided into NMDA (Nmethyl-D-aspartate) and AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) subtypes, and were previously thought to be functionally and physically limited to the synaptic surfaces of neuronal cells. Recently, however, it has been demonstrated that gliomas both secrete flutamate and have AMPA flutamate receptors that contribute to the proliferation, migration, and neurotoxicity of malignant gliomas. Inhibition of flutamate signaling has been shown to inhibit glioma growth and invasion in preclinical models. Talampanel is the prototype of a novel class of potent AMPA receptor inhibitors, and has demonstrated significant antiseizure activity and excellent tolerability in clinical studies of epilepsy. We now propose a phase II trial of talampanel as a novel new anti-glioma therapy in patients with recurrent high-grade gliomas.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with histologically proven intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified). Patients must have unequivocal evidence for tumor progression by MRI or CT scan. This scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: a) They have recovered from the effects of surgery. b) Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/MRI should be done: no later than 96 hours in the immediate post-operative period or; at least 4 weeks post-operatively, and; within 14 days of registration, and; on a steroid dosage that has been stable for at least 5 days. If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days. Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry. All patients must sign an informed consent, or if cognitively impaired, their assigned DPA, indicating that they are aware of the investigational nature of this study. Patients will designate a power of attorney. Patients must be greater than or equal to 18 years old, and with a life expectancy greater than 8 weeks. Patients must have a Karnofsky performance status of greater than or equal to 60. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy, two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week from non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed by the Study Chair. Patients must have adequate bone marrow function (ANC greater than 1,500/mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 10 gm/dl), adequate liver function (SGOT and bilirubin less than 2 times ULN), and adequate renal function (serum creatinine less than 1.5 mg/dL otherwise a measured 24-hour creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. Eligibility level for platelets may not be reached by transfusion. Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy. Patients must not have active infection requiring IV antibiotics. Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with Talampanel. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use two forms of adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner). Men should also protect their partner from becoming pregnant through use of condoms with spermicide, vasectomy or abstinence. EXCLUSION CRITERIA: Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases that would significantly increase the risk of using talampanel are ineligible. No concurrent use of other standard chemotherapeutics or investigative agents. Patients known to have an active, life-threatening malignancy, other than glioma. Routine physical examination and baseline blood tests (CBC and platelets, SGOT, alkaline phosphatase, total and direct bilirubin, electrolytes, BUN, creatinine) and levels of any anti-epileptic agent the patient is taking that is routinely measured (phenytoin, valproate, carbamazepine, phenobarbitol). A contrast-enhanced MRI scan (CT scan if patient is unable to undergo a MRI scan) of the head will be obtained within 2 weeks of registration). Health-related Quality of Life (HRQL): HRQL will be assessed with the Functional Assessment of Cancer Therapy (FACT-Br). Administration of the FACT-Br within 2 weeks of trial entry. The FACT-Br is a reliable and valid questionnaire to assess health-related quality of life in patients with brain cancer. The questionnaire consists of 45 one-sentence statements and is organized into five sections where physical, social/family and functional subscales comprise of 7 statements, emotional subscale comprises of 6 statements, and brain tumor specific subscale comprises of 18 statements. The questionnaire is self-administered and filled in by patients. Patients rate the statements on 5 point rating scale where 0 equals not at all and 4 equals very much. In this study, the raw scoring will be used to calculate subscale domain scores as well as total summary score. Negatively stated items have to be reversed before calculation of the scores. A higher score represents a more favorable response. If there are less or equal 50% of data in the subscale missing (a minimum of 4 items answered), the subscale score will be prorated. If more than 50% of data in the subscale are missing, the scores cannot be calculated. If overall response rate for the 45 items is less or equal 80%, the scores cannot be calculated.
Total Enrollment: 91
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030207; 03-C-0207
Study Start Date: May 28, 2003
Record last reviewed: April 21, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061685
Other Glioma Studies:
1. Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
2. Phase I trial of CC-8490 for the treatment of subjects with recurrent/refractory high-grade gliomas
3. Natural History of Patients with Brain and Spinal Cord Tumors
4. Safety and effectiveness study of G207, a tumor-killing virus, in patients with recurrent brain cancer
5. Evaluation of Factors in Human Brain Tumors
Related Studies:
Other Glioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
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