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Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme Clinical research trials and Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme. Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme clinical trial. Participants frequently get the best healthcare available for their Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme  Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
For Condition: Glioblastoma Multiforme
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: Study of Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. - Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy) - Must have past biopsy samples available for central pathology review - Must have evidence on Gd-MRI of progressive/recurrent disease - Must have measurable disease on Gd-MRI obtained within 14 days prior to start of study treatment - Must be at least 18 years of age - Must have a Karnofsky Performance Status score of at least 70 - If being treated with steroids, the steroid dose must be stable or decreasing for 1 week prior to randomization - If being treated with anticonvulsants, must have no change in the type of anticonvulsants for 2 weeks prior to randomization - All acute toxic effects (except for alopecia) of any prior treatment must have resolved or are no greater than grade 1 (NCI Common Toxicity Criteria, Version 2.0) - Baseline laboratory data must be within the following limits: absolute neutrophil count at least 1500; platelets at least 100,000; hemoglobin at least 9.0 g/dL; serum creatinine no greater than 1.5 mg/dL, total serum bilirubin no greater than 1.5 times the upper limit of the normal range; SGOT and SGPT no greater than 2.5 times the upper limit of the normal range; albumin at least 3.0 g/dL, serum or urine pregnancy test (for females of childbearing potential) negative within 7 days prior to start of study treatment - At least 6 weeks must have elapsed since completion of prior nitrosurea therapy; at least 4 weeks since completion of prior temozolomide therapy - Must have written informed consent - Must be able and willing to comply with study procedures - Must have received prior treatment with radiotherapy (conventional fractionated external beam) and (neo)adjuvant/concurrent chemotherapy (with a temozolomide- or a nitrosurea-based containing )regimen for GBM - Must not have received prior treatment (except for surgical debulking) of first relapse (progression or recurrence) of GBM - Must not have received prior treatment with another topoisomerase-I inhibitor (e.g. irinotecan, topotecan, rubitecan) - Must not have had radiosurgery or radiotherapy within 1 month prior to randomization - Must not have had prior brachytherapy or chemotherapy wafer implantation - Must not have had prior high-dose chemotherapy with bone marrow or stem cell support - Must not receive concomitant treatment with any other investigational agent or anti-cancer treatment during the study - Must not be currently enrolled in another therapeutic clinical trial for the treatment of GBM - Must not currently (or in the past 5 years) have other malignancies (except for adequately treated basal cell or squamous cell skin cancer or non-invasive cervical cancer) - Must not have any of the following in the past 6 months: myocardial infarction (heart attack), severe/unstable angina, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (stroke), or transient ischemic attack (TIA) - Must not have had any of the following in the past 2 months: pulmonary embolus (blood clot in lungs), deep venous thrombosis (blood clot in veins), or other significant thromboembolic event - Must not have an ongoing cardiac dysrhythmia (abnormal heart rhythm) of grade 2 or higher (NCI Common Toxicity Criteria, Version 2.0) - Must not have known human immunodeficiency virus (HIV) infection - Must not be pregnant or breastfeeding. Patients (male and female) must be surgically sterile (or postmenopausal for females) or must agree to use effective contraception during the period of study treatment - Must not be inappropriate for entry into the study, in the judgment of the investigator
Total Enrollment:
Location and Contact Information:
Pfizer Investigational Site *Recruiting*
Evanston, Illinois,
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Unknown, , 169608
Singapore
Recruiting
Pfizer Investigational Site *Recruiting*
Orlando, Florida, 32804
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Split, ,
Croatia
Recruiting
Pfizer Investigational Site *Recruiting*
HRADEC KRALOVE, , 50005
Czech Republic
Recruiting
Pfizer Investigational Site *Recruiting*
Orlando, Florida, 32803
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Halifax, Nova Scotia,
Canada
Recruiting
Pfizer Investigational Site *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Edison, New Jersey, 08818
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting
Pfizer Investigational Site *Recruiting*
Dallas, Texas, 75390
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Lebanon, New Hampshire, 03756
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Summit, New Jersey, 07902
United States
Recruiting
Pfizer Investigational Site *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting
Additional Information:
Study ID Numbers: EDOAGL-8725-001;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068952
Other Glioblastoma Multiforme Studies:
1. Phase I Study of Tipifarnib with Radiation Therapy to Treat Glioblastoma Multiforme
2. Pre-operative IL13-PE38QQR in Patients with Recurrent or Progressive Malignant Glioma
3. Histologic Effect/Safety of Pre/Post-Operative IL13-PE38QQR in Recurrent Resectable Supratentorial Malignant Glioma Patients
4. Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
5. The PRECISE Trial: Survival Study of IL13-PE38QQR Compared to GLIADEL® Wafer in Patients with Recurrent Glioblastoma Multiforme
Related Studies:
Other Glioblastoma Multiforme Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Study of IV Edotecarin vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
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