|
OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy Clinical research trials and OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy. OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy clinical trial. Test subjects typically obtain the finest healthcare available for their OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "O" Clinical Trials Conditions > OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy  OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy
OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy
For Condition: Glioma,Meningioma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine 1) a safe dose of the experimental drug OSI-774 in patients with malignant glioma (a type of cancerous brain tumor), and 2) the drug's effectiveness in treating this disease. Genetic changes in glioma cells may lead to an excess of certain growth factors and the receptors (proteins on cell surfaces) that they bind to, resulting in uncontrolled tumor growth. A growth factor called EGF is seen in high concentrations in malignant gliomas and may be an important contributor to the growth of these tumors. OSI-774 blocks the EGF receptor and may prevent it from causing tumor growth. Patients 18 years of age and older with a primary glioma that is growing and does not respond to standard treatment, such as surgery, chemotherapy or radiation therapy, may be eligible for this study. Candidates will be screened with physical and neurologic examinations, blood and urine tests, an electrocardiogram (ECG), and magnetic resonance imaging (MRI) or computed tomograpy (CT) of the head. There are two phases to this study. Participants will be assigned to phase I or phase II depending on whether they are taking certain anti-seizure medicines. Some seizure medicines can affect the metabolism and blood levels of OSI-774. Phase I will examine the safety of OSI-774 in patients who are taking such medications. Phase II will examine the effectiveness of OSI-774 in controlling tumor growth in 1) patients who are not taking such seizure medications, and 2) patients who are taking such medications, after the safe dose of OSI-774 has been determined in phase I. All patients will take OSI-774 tablets daily for up to a year, or possibly longer, as long as they do not develop unacceptable drug side effects and their tumor either remains stable or shrinks. They will have routine blood tests every 1 to 2 weeks and a physical examination and MRI or CT scans every 8 weeks. Additional blood tests will be done to measure blood levels of OSI-774, blood levels of a protein that may alter OSI-774 levels, and whether EGF receptor can be detected in the blood. Patients may also be asked to undergo a scan called dynamic MR with spectroscopy- a test that is identical in experience to standard MRI-or positron emission tomography (PET), which is similar to CT and MRI. These scans, although not required for this study, may be helpful in determining the effect of OSI-774 on the glioma. Patients in phase II who were scheduled for surgery before entering the study will have the option of participating in an additional study. They will receive OSI-774 for 7 days before surgery, but not on the day of surgery. During surgery, a piece of tumor tissue will be analyzed for the effects of OSI-774 on certain pathways of cell growth. With the patient's permission, some of the tissue from this surgery, and from any previous brain surgeries, will be sent to the company providing OSI-774 for further investigation. After patients have recovered from surgery, they will continue OSI-774 treatment as described above.
Details: Malignant gliomas are the most common brain tumor in adults, with about 15,000 new cases/year in the U.S. Despite progress made using combination therapies including surgery, radiation and/or chemotherapy, the treatment of malignant gliomas remains problematic with a typical median survival of 6-12 months for patients with newly diagnosed glioblastoma multiforme and 24-36 months for patients with anaplastic astrocytoma. The time to tumor progression of patients with recurrent glioblastomas (GBM) is nine weeks and the median survival is 25 weeks, while for recurrent anaplastic astrocytomas (AA), the time to tumor progression is 13 weeks and the median survival is 47 weeks. Chemotherapy treatment for malignant gliomas has limitations given the low activity of available antineoplastic agents, compromised delivery of these agents to at least partially privileged intracranial sites, the emergence or de-novo presence of resistance to these agents, and the sensitivity of the brain to irreversible damage from any therapeutic modality. Effective agents with novel mechanisms of action need to be evaluated in malignant glioma.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: ELIGIBILITY CRITERIA: Patients who are on EIAEDs will be considered for the phase I portion of the study until an MTD has been established after which these patients on EIAEDs will then partake in the phase II portion of the study. Patients who are not on any EIAEDs will immediately be evaluated on the phase II portion. Patients with histologically proven intracranial malignant glioma or recurrent meningiomas 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 with recurrent or progressive benign or malignant meningiomas are also eligible for treatment based on histology or radiographic findings consistent with a meningioma. For patients on the phase I and II portion of the study, patients will also be eligible if the original histology was low grade glioma and a subsequent histological diagnosis of a malignant glioma is made. Patients with recurrent or progressive benign or malignant meningioma are eligible for phase I and II. They will be assigned to accrual groups based on whether they are on an EIAED or a non-EIAED. Patients with glioblastoma multiforme who have completed external beam radiation therapy with no evidence of progression will be eligible for phase I and II. They will be assigned to accrual groups based on whether they are on an EIAED or a non-EIAED. Radiation must have been completed no more than 6 weeks prior to starting OSI-774. For the phase I and II portions of the study, patients must have shown unequivocal evidence for tumor recurrence or progression by MRI or CT scan. Patients who had tumor recurrence or progression and have undergone gross total resection of their tumor, with no measurable disease, are still eligible if a treatment response or failure can be evaluated. A scan should be performed within 14 days prior to registration and 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. For phase II patients in the preoperative component, only a scan showing progression is required. Following surgery, a scan should be done no later than 96 hours or at least 4 weeks from surgery. Treatment with OSI-774 postoperatively should start within 14 days of the scan. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: They have recovered from the effects of surgery. Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. Only patients who are eligible for participation in the phase II component of the study may be enrolled in a pre-operative study to evaluate biological and/or tissue correlates. 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 4-6 weeks post-operatively. If the 96 hour scan is more than 2 weeks from 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 stable steroids for at least 5 days. The baseline on-study MR/CT is performed within 14 days of registration and on a steroid dosage that has been stable. If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required on stable steroids for 5 days. The same type of scan, MRI or CT, must be used throughout the period of protocol treatment for tumor measurement. For both the phase I and II portions, patients with malignant gliomas with progressive disease 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. Patients with meningiomas do not require prior radiation therapy to be eligible; however, if they have had radiation they must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry. For the patients with glioblastoma multiforme who have completed external beam radiation and do not have progressive disease based on MRI or CT scan, will be eligible for treatment with OSI-774. Radiation therapy must have been completed no more than 6 weeks prior to beginning study drug and patients must have recovered fro many toxicities related to acute radiation effects. Prior Radiation therapy: Malignant Gliomas and Meningiomas External Beam: Patients with progressive disease between 4 and 12 weeks after the completion of radiation should have clear evidence of disease progression on MRI scan. A PET or thallium SPECT, MR spectroscopy, or surgical documentation may be done at the discretion of the treating physician if there is a question of radiation changes or necrosis versus progressive disease. Interstitial brachytherapy or stereotactic radiosurgery: Patients must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium scanning, MR spectroscopy or surgical documentation of disease. Prior therapy: For the phase I component, patients must have had treatment for no more than 3 prior relapses and is limited to 2 prior treatments with chemotherapy or biologic agents. For the cohort of patients with stable glioblastoma multiforme, no prior chemotherapy (including gliadel wafers) is allowed. For the phase II component, patients may have had treatment for no more than 2 prior relapses and is limited to 2 prior treatments with chemotherapy or biologic agents. For the cohort of patients with stable glioblastoma multiforme, no prior chemotherapy (including gliadel wafers) is allowed. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information. Patients must be registered in the North American Brain Tumor Consortium Data Management Center (NABTC DMC) database prior to treatment with study drug. 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 prior cytotoxic therapy and/or at least 2 weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count), 4 weeks for R115777, SU5416, STI-571 or other experimental biologic agents. Patients must have adequate bone marrow function (WBC greater than or equal to 3,000/microliters, ANC greater than or equal to 1,500/mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 10 mg/dl), adequate liver function (SGOT and bilirubin less than 1.5 times ULN), and adequate renal function (creatinine less than 1.5 mg/dL) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may 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 patient's ability to tolerate this therapy. Patients with abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test) are ineligible. Patients who are found to have dry eyes on ophthomalogical evaluation but otherwise normal exam, and do not have dry eyes as part of a syndrome as listed above, are eligible for study participation. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetics interactions with OSI-774. HIV testing is not required for study participation. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. Patients must not have active infection. Patients must not be pregnant/breast feeding and must practice adequate contraception. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and continue approximately 12 weeks after the study is completed. Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism. Patients must not have any serious intercurrent medical illness. Patients must not have received prior therapy with (OSI-774) or other EGFR inhibitors.
Total Enrollment: 158
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: 030114; 03-C-0114
Study Start Date: February 20, 2003
Record last reviewed: January 27, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055276
Other Meningioma Studies:
1. NF2 Natural History Consortium
2. OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy
3. STI571 to Treat Malignant Brain Tumors
4. ST1571 to Treat Patients with Recurrent Meningiomas
Related Studies:
Other Meningioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy
|
|
|
|
|
|
|
|
