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Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma Clinical research trials and Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma. Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma clinical trial. Subjects often receive the most expert healthcare possible for their Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma  Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
For Condition: Mixed Gliomas,adult brain stem glioma,Quality of Life,adult glioblastoma multiforme,adult anaplastic oligodendroglioma,adult anaplastic astrocytoma,recurrent adult brain tumor
Status: Completed
Sponsor(s): Barrett Cancer Center ,
Synopsis: RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma.
Details: OBJECTIVES: I. Assess the toxic effects of concurrent permanent iodine I 125 interstitial seed implants and polifeprosan 20 with carmustine implant (Gliadel wafers) in patients with recurrent or refractory malignant glioma. II. Assess preliminary efficacy of this regimen in terms of progression free survival and overall survival of these patients. III. Assess impact of this regimen on the quality of life and performance status of these patients. IV. Assess site of tumor progression following this regimen in these patients. V. Assess the relationship between progression free survival and the MIB-1 proliferative index of the resected malignant glioma. PROTOCOL OUTLINE: This is a dose escalation study. Patients undergo craniotomy with the intent to obtain a complete resection of enhancing tumor. Following maximum tumor removal, iodine I 125 seeds and up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) are implanted into the resected tumor cavity. Cohorts of 6 patients each receive increasing numbers of Gliadel wafers placed into the tumor cavity. Quality of life is assessed at baseline, then every 3 months, and at tumor progression. Patients are followed monthly until death. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent or refractory glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma (mixed glioma), anaplastic pleomorphic xanthoastrocytoma, or malignant dedifferentiation from prior low grade glioma; Tumor in first relapse - Measurable disease by MRI scan; Enhancing lesion amenable to gross total resection - Postoperative resection cavity not communicating freely with ventricular system --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered; No prior polifeprosan 20 with carmustine implant (Gliadel wafers); Prior adjuvant chemotherapy allowed; No other concurrent chemotherapy - Endocrine therapy: Patient on stable steroid therapy for at least 2 weeks prior to study; No concurrent hormonal agents - Radiotherapy: Prior radiosensitization allowed and recovered; Prior external beam radiotherapy required and recovered; No concurrent radiotherapy (including palliative) - Surgery: Prior surgery or biopsy required and recovered - Other: No prior iodine I 125 seed implants; Concurrent alternative therapy allowed; No other concurrent antineoplastic therapy; No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Greater than 8 weeks - Hematopoietic: Absolute neutrophil count greater than 1,000/mm3; Hemoglobin greater than 10.0 g/dL; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); SGOT or SGPT less than 2.5 times ULN - Renal: Not specified Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No AIDS-related illness; No other malignancy within past 5 years, except: Basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix; No psychological, familial, sociological, or geographical conditions that would interfere with study compliance; No active infection requiring systemic antibiotics; No nonmalignant systemic disease considered to increase medical risk
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertAlbright, Study Chair, Barrett Cancer Center
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Additional Information:
Study ID Numbers: CDR0000067042; UCMC-98724,NCI-V99-1543,UCMC-55853
Study Start Date: April 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003876
Other Adult Anaplastic Astrocytoma Studies:
1. Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
2. Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
3. Carmustine in Treating Patients With Recurrent Malignant Glioma
4. Sirolimus in Treating Patients With Glioblastoma Multiforme
5. Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
Related Studies:
Other adult anaplastic astrocytoma Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
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