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Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme



Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme

For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Norris Cotton Cancer Center
Synopsis: RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.
Details: OBJECTIVES: I. Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme. II. Determine the response, time to tumor progression, and overall survival of these patients treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation study. Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. Within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes. Stable or responding patients may receive a second treatment 1 month later. Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities. PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven glioblastoma multiforme with evidence of epidermal growth factor receptor (EGFR) expression on tumor cell surfaces: No astrocytoma, anaplastic astrocytoma, or oligodendroglioma; No infratentorial or multifocal tumor - Recurrence or progression following at least one prior therapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) - Endocrine therapy: Concurrent steroid therapy allowed - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Greater than 2 months - Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 10 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; ALT, AST, and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) - Renal: Creatinine no greater than 2.0 times ULN - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other medical or psychiatric illness that would preclude study; No other concurrent malignancy except nonmelanoma skin cancer
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CamiloFadul,  Study Chair,  Norris Cotton Cancer Center

Norris Cotton Cancer Center
Lebanon,  New Hampshire,  03756-0002
United States
 


Additional Information:
Study ID Numbers:  CDR0000067815;  NCI-G00-1783,DMS-9705
Study Start Date: March 1997
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005813

Other Adult Glioblastoma Multiforme Studies:
1. Carmustine in Treating Patients With Recurrent Malignant Glioma

2. Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma

3. Irinotecan in Treating Patients With Recurrent Malignant Glioma

4. Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma

5. Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

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