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Biological Therapy in Treating Patients With Primary or Advanced Glioma 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 in Treating Patients With Primary or Advanced Glioma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Biological Therapy in Treating Patients With Primary or Advanced Glioma Clinical research trials and Biological Therapy in Treating Patients With Primary or Advanced Glioma 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 in Treating Patients With Primary or Advanced Glioma. Biological Therapy in Treating Patients With Primary or Advanced Glioma 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 in Treating Patients With Primary or Advanced Glioma clinical trial. Human subjects often obtain the finest healthcare possible for their Biological Therapy in Treating Patients With Primary or Advanced Glioma 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 in Treating Patients With Primary or Advanced Glioma  Biological Therapy in Treating Patients With Primary or Advanced Glioma
Biological Therapy in Treating Patients With Primary or Advanced Glioma
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,Mixed Gliomas,recurrent adult brain tumor
Status: Suspended
Sponsor(s): Staten Island University Hospital ,
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma. PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.
Details: OBJECTIVES: - Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas. - Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients. OUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction. Patients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter. Disease restaging is done every 8-12 weeks. PROJECTED ACCRUAL: A total of 30 patients per year will be enrolled.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma) - Must be a candidate for neurosurgical biopsy or tumor debulking PATIENT CHARACTERISTICS: Age: - 18 and over Performance Status: - Karnofsky 60-100% Life Expectancy: - Greater than 4 months Hematopoietic: - Granulocytes greater than 1,500/mm^3 - Platelet count greater than 50,000/mm^3 - PT and PTT within normal limits Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal Renal: - Creatinine less than 1.5 mg/dL - Creatinine clearance greater than 60 mL/min Cardiovascular: - No congestive heart failure - No coronary artery disease - No serious cardiac arrhythmias - No prior myocardial infarction Pulmonary: - No major pulmonary problems Other: - No history of neurologic disease (except related to brain tumor) - No psychosis - No impaired cognitive function - No significant concurrent medical illness - No active infection requiring antibiotic therapy - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device - No hepatitis B or C - HIV negative - No prior autoimmune disease - Allergy to gentamicin is allowed PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 weeks since prior immunotherapy and recovered - No concurrent immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered - No concurrent chemotherapy Endocrine therapy: - Reduction or elimination of corticosteroids - Not greater than 0.15 mg/kg/day dexamethasone equivalent Radiotherapy: - At least 6 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - Prior surgery is allowed Other: - Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertaHayes, Study Chair, Staten Island University Hospital
Staten Island University Hospital
Staten Island, New York, 10305
United States
Additional Information:
Study ID Numbers: CDR0000065739; SIUH-RP-96-004,NCI-V97-1326
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003067
Other Adult Anaplastic Astrocytoma Studies:
1. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
2. Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
3. BMS 247550 in Treating Patients With Recurrent Glioma
4. O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
5. Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
Related Studies:
Other adult anaplastic astrocytoma Clinical Trials
Other New York Clinical Trials
Other Staten Island Clinical Trials
Biological Therapy in Treating Patients With Primary or Advanced Glioma
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