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Home > "I" Clinical Trials Conditions > Immunotoxin Therapy in Treating Patients With Malignant Glioma  Immunotoxin Therapy in Treating Patients With Malignant Glioma
Immunotoxin Therapy in Treating Patients With Malignant Glioma
For Condition: adult anaplastic astrocytoma,recurrent adult brain tumor,adult glioblastoma multiforme,Mixed Gliomas
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignantglioma. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.
Details: OBJECTIVES: - Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma. - Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen. - Determine the toxic effects of this drug at the MTD in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven malignant glioma (grade 3 or 4) - Anaplastic astrocytoma - Glioblastoma multiforme - Malignant mixed oligoastrocytoma - Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study - Must have undergone supratentorial brain tumor surgery or biopsy - Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study - Must have solid portion measuring 1.0-5.0 cm in maximum diameter - Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm - No tumor crossing the midline - No leptomeningeal tumor dissemination - No impending herniation or spinal cord compression - No uncontrolled seizures PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 10 g/dL - Platelet count at least 100,000/mm^3 Hepatic: - PT and PTT no greater than upper limit of normal (ULN) - SGOT and SGPT no greater than 2.5 times ULN - Bilirubin no greater than 2.0 mg/dL Renal: - Not specified Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior intralesional chemotherapy for malignant glioma - At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered - No concurrent chemotherapy Endocrine therapy: - Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study Radiotherapy: - See Disease Characteristics - No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma Surgery: - See Disease Characteristics Other: - Recovered from any prior therapy - No other concurrent investigational agent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonWeingart, Study Chair, Sidney Kimmel Cancer Center
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Jon Weingart 410-614-3052
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Kelly 336-716-4049
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting E. Chiocca 617-726-3779
National Institute of Neurological Disorders and Stroke *Recruiting*
Bethesda, Maryland, 20892-1414
United States
Recruiting Edward Oldfield 301-496-5728
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Steven Brem 813-979-3063
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jane Alavi 215-662-6319
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting David Lawson 404-778-4189
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Mark Rosenblum 313-916-1340
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Dennis Vollmer 210-567-5625
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Alyssa Reddy 205-939-9285
Additional Information:
Study ID Numbers: CDR0000068211; NEOPHARM-IL13PEI-001-R03,JHOC-NABTT-9903,NABTT-9903,NEOPHARM-TS-G1-TI4
Study Start Date:
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006268
Other Adult Glioblastoma Multiforme Studies:
1. Antineoplaston Therapy in Treating Patients With Brain Stem Glioma
2. Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
3. Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
4. Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
5. Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immunotoxin Therapy in Treating Patients With Malignant Glioma
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