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Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma Clinical research trials and Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma clinical trial. Human subjects often obtain the finest healthcare possible for their Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma  Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
For Condition: adult noninfiltrating astrocytoma,adult infiltrating astrocytoma,Adult Oligodendroglioma,adult brain tumor
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrentastrocytoma or oligodendroglioma.
Details: OBJECTIVES: - Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and adoptive immunotherapy, in terms of time to progression and median and one-year survival, in patients with primary or recurrent malignant astrocytoma or oligodendroglioma. - Determine the immunogenicity of malignant gliomas in patients treated with this regimen. OUTLINE: Patients are stratified according to extent of disease, extent of antigen-specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender. Patients undergo tumor resection on week 1. Patients without recurrent disease receive local radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may receive up to 3 additional vaccinations every 2 weeks until a response is detected. Patients undergo peripheral blood mononuclear cell collection on week 14 followed by monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive one additional course of immunotherapy as above. Patients are followed at 1 week, monthly for 3 months, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven grade II, III, or IV astrocytoma or oligodendroglioma - Evidence of primary or recurrent tumor by MRI - Resectable disease - At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0 or 1 Life expectancy: - At least 6 months Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least lower limit of normal - No active or recent uncontrolled bleeding Hepatic: - Bilirubin normal - SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal: - Creatinine normal Other: - Able to be weaned off steroids - Negative stool guaiac - No impaired immunity - No uncontrolled diabetes - No active uncontrolled infections - No other serious disease - No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix - No psychological, familial, sociological, or geographical conditions that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent chemotherapy except for progressive disease Endocrine therapy: - See Disease Characteristics Radiotherapy: - Radium implants allowed Surgery: - Not specified Other - At least 1 week since prior therapy and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndrewSloan, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Andrew Sloan 313-966-5007
Additional Information:
Study ID Numbers: CDR0000067243; WSU-C-1403-BT,NCI-G99-1567
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004024
Other Adult Oligodendroglioma Studies:
1. Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
2. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
3. BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
4. Antineoplaston Therapy in Treating Patients With Brain Tumors
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer
Related Studies:
Other Adult Oligodendroglioma Clinical Trials
Other Michigan Clinical Trials
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Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
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