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EMD 121974 in Treating Patients With Progressive or Recurrent Glioma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on EMD 121974 in Treating Patients With Progressive or Recurrent Glioma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. EMD 121974 in Treating Patients With Progressive or Recurrent Glioma Clinical research trials and EMD 121974 in Treating Patients With Progressive or Recurrent Glioma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like EMD 121974 in Treating Patients With Progressive or Recurrent Glioma. EMD 121974 in Treating Patients With Progressive or Recurrent Glioma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a EMD 121974 in Treating Patients With Progressive or Recurrent Glioma clinical trial. Participants frequently obtain the most expert healthcare available for their EMD 121974 in Treating Patients With Progressive or Recurrent Glioma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > EMD 121974 in Treating Patients With Progressive or Recurrent Glioma  EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
For Condition: adult anaplastic astrocytoma,adult glioblastoma multiforme,adult anaplastic oligodendroglioma,recurrent adult brain tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in patients with progressive or recurrent malignant glioma. - Determine the 6-month progression-free survival, clinical response rate, duration of progression-free survival, and overall survival in patients treated with this drug. - Determine the effects of this drug on tumor perfusion, measured with magnetic resonance perfusion scan, and markers for angiogenesis in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 6 patients will be accrued for phase I of this study within 2-3 months. A total of 23-38 patients will be accrued for phase II of this study within 5-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy - Eligible subtypes: - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Glioblastoma multiforme - Prior low-grade glioma that has progressed to a high-grade glioma (by biopsy) after radiotherapy and/or chemotherapy allowed - Measurable disease by volumetric and magnetic resonance perfusion scan - Prior biopsy or resection of recurrent brain tumor allowed 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 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - Transaminases no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No advanced coronary artery disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious concurrent infection or medical illness that would preclude study - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer - No history of wound healing disorders - No peptic ulcer disease within the past year - Mini mental score of at least 15 - Willing and able to undergo MRI PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No more than 2 prior chemotherapy regimens Endocrine therapy: - Prior corticosteroids allowed if on stable dose for at least 5 days prior to study - Concurrent corticosteroids (e.g., dexamethasone) allowed as clinically needed Radiotherapy: - See Disease Characteristics - At least 3 months since prior radiotherapy and recovered Surgery: - See Disease Characteristics - At least 1 week since prior surgery and recovered - No concurrent elective surgery or dental extractions Other: - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LouisNabors, Study Chair, UAB Comprehensive Cancer Center
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Additional Information:
Study ID Numbers: CDR0000068098; NABTT-9911,JHOC-NABTT-9911
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006093
Other Recurrent Adult Brain Tumor Studies:
1. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
2. Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas
3. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
4. Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
5. Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
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