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Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme Clinical research trials and Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme. Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme clinical trial. Participants oftentimes recieve the finest healthcare available for their Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme  Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
For Condition: recurrent adult brain tumor,adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of glufosfamide in treating patients who have recurrent glioblastoma multiforme.
Details: OBJECTIVES: I. Determine the activity of glufosfamide, in terms of objective response rate and/or progression-free survival at 6 months, in patients with recurrent glioblastoma multiforme. II. Determine the duration of objective response in patients treated with this regimen. III. Determine the toxic effects and pharmacokinetic profile of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive glufosfamide IV over 60 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for a minimum of 6 months or until progression. Patients with an objective complete response receive a maximum of 2 additional courses of treatment after confirmation of response. Patients are followed every 6 weeks until progression. PROJECTED ACCRUAL: A total of 28 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 or cytologically confirmed glioblastoma multiforme - Recurrent disease by CT scan or MRI - At least 1 bidimensionally measurable target lesion at least 2 cm in the largest diameter --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent prophylactic growth factors (e.g., filgrastim (G-CSF)) - Chemotherapy: No more than 1 prior chemotherapy regimen as adjuvant therapy or for recurrent disease; At least 6 weeks since prior chemotherapy - Endocrine therapy: Stable or decreasing dose of corticosteroids for at least 1 week prior to study - Radiotherapy: At least 3 months since prior radiotherapy to the brain; No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the disease recurrence is histologically confirmed - Surgery: No prior surgery (except biopsy) for recurrent brain tumor; At least 3 months since prior surgery for primary brain tumor - Other: No other concurrent anticancer agents; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN; AST and ALT no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance at least 60 mL/min - Cardiovascular: Cardiac function normal; No history of ischemic heart disease within the past 6 months; 12 lead ECG normal - Other: No other prior or concurrent malignancy except cone biopsied cervical cancer or adequately treated basal cell or squamous cell skin cancer; No unstable systemic disease; No active uncontrolled infection; No psychological, familial, sociological, or geographical condition that would preclude study; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Martinvan Den Bent, Study Chair, EORTC Early Clinical Studies Group
Kaiser Franz Josef Hospital
Vienna (Wien), , A-1100
Austria
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Centre Eugene Marquis
Rennes, , 35064
France
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Institut Gustave Roussy
Villejuif, , F-94805
France
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00161
Italy
Academisch Ziekenhuis Utrecht
Utrecht, , 3508 GA
Netherlands
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Centre Antoine Lacassagne
Nice, , 06189
France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
Kantonsspital - St. Gallen
St. Gallen, , CH-9007
Switzerland
Azienda Ospedaliera di Padova
Padova (Padua), , 35128
Italy
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , 1093
Portugal
CHU Pitie-Salpetriere
Paris, , 75651
France
Centre Leon Berard
Lyon, , 69373
France
University of Ioannina
Ioannina, , GR-45110
Greece
Schneider Children's Medical Center of Israel
Petah-Tikva, , 49202
Israel
Additional Information:
Study ID Numbers: CDR0000068528; EORTC-16994G-26002
Study Start Date: January 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014300
Other Adult Glioblastoma Multiforme Studies:
1. Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
2. Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain
3. CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
4. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
5. Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Clinical Trials
Other Nantes-Saint Herblain Clinical Trials
Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
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