Biological Therapy in Treating Patients With Glioblastoma Multiforme
NCT ID: NCT00003185
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1997-08-31
1998-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients with glioblastoma multiforme.
Detailed Description
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OUTLINE: Patients are vaccinated with irradiated, autologous tumor cells plus sargramostim (GM-CSF) intradermally near draining lymph nodes in the groin or axillary regions. This is then followed by 3 consecutive days of intradermal injections of GM-CSF only, directly into the vaccine sites. Enlarged lymph nodes are then removed 7-10 days later and activated with staphylococcal enterotoxin A (SEA) and interleukin-2 (IL-2). T cells are expanded ex vivo over approximately 10 days. 1-2 days prior to infusion, oral cyclophosphamide is administered as a one time dose. The lymphocyte infusion is then administered intravenously. Based on availability, patients may receive vaccine boosts with additional injections of irradiated autologous tumor cells thawed from the original, cryopreserved collection. Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 2 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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autologous tumor cell vaccine
sargramostim
tumor-draining lymph node lymphocyte therapy
cyclophosphamide
conventional surgery
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC greater than 2000/mm3 Platelet count greater than 100,000/mm3 Hepatic: No active infection with hepatitis B Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 1 month after study No active collagen vascular or autoimmune disease No prior severe reaction to any blood product No other prior malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ or the cervix, or stage I or II cancer in complete remission Not immunologically compromised due to chronic conditions Not allergic by standard skin testing HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy with immunomodulatory effects (e.g., interleukin-2, interferon alfa) Chemotherapy: No prior or concurrent local or systemic chemotherapy Endocrine therapy: At least 1 week since prior corticosteroid therapy No concurrent corticosteroid therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent antiproliferatives or immunosuppressants
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Cleveland Clinic
OTHER
Principal Investigators
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Suyu Shu, PhD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Countries
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References
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Plautz GE, Barnett GH, Miller DW, Cohen BH, Prayson RA, Krauss JC, Luciano M, Kangisser DB, Shu S. Systemic T cell adoptive immunotherapy of malignant gliomas. J Neurosurg. 1998 Jul;89(1):42-51. doi: 10.3171/jns.1998.89.1.0042.
Other Identifiers
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CCF-BB-IND-6154
Identifier Type: -
Identifier Source: secondary_id
NCI-H98-0008
Identifier Type: -
Identifier Source: secondary_id
CDR0000066013
Identifier Type: -
Identifier Source: org_study_id