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Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme 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 Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme Clinical research trials and Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme 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 Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme 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 Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme clinical trial. Participants frequently obtain the most expert healthcare available for their Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme 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 > "I" Clinical Trials Conditions > Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I/II trial to study the effectiveness of irinotecan plus radiation therapy followed by irinotecan and carmustine in treating patients who have newly-diagnosedglioblastoma multiforme.
Details: OBJECTIVES: - Determine the maximum tolerated dose of adjuvant irinotecan when administered concurrently with radiotherapy and then with carmustine in patients with newly diagnosed glioblastoma multiforme. (Phase I for patients receiving enzyme-inducing anticonvulsants [EIACs] closed to accrual effective 11/17/2003; only open for patients receiving non-EIACs) (Phase II only open for patients receiving EIACs) - Determine the safety of this regimen in these patients. - Determine survival of patients treated with this regimen. - Assess the toxic effects of this regimen in these patients. - Determine whether the dose of irinotecan chosen produces radiosensitizing plasma concentrations of SN-38 in these patients. - Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of irinotecan in these patients treated with this regimen. OUTLINE: This is a pilot, dose-escalation study of irinotecan. Patients are stratified according to receipt of concurrent enzyme-inducing anticonvulsants (EIACs) (yes vs no). (Phase I for patients receiving EIACs closed to accrual effective 11/17/2003; only open for patients receiving non-EIACs) (Phase II only open for patients receiving EIACs). - Patients receive carmustine IV over 2 hours on day 1 of courses 2-5 and irinotecan IV over 90 minutes (beginning immediately after carmustine infusion) on days 1, 8, 22, and 29 of courses 1-5. Patients also undergo radiotherapy 5 days a week for 6 weeks concurrently with course 1 only. Treatment repeats every 6 weeks for 5 courses in the absence of unacceptable toxicity. Cohorts of 6 patients receive escalating doses of irinotecan until the recommended dose for phase II is determined. The recommended dose for phase II is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. - Phase II (only open for patients receiving EIACs): Patients receive irinotecan at the recommended dose, carmustine, and cranial irradiation as in phase I. Patients with disease progression are followed every 3 months for 5 years and then annually for up to 10 years. Patients taken off study for reasons other than disease progression are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 12-48 patients (6-24 per stratum) will be accrued for phase I within 2-4 months (phase I for patients receiving enzyme-inducing anticonvulsants [EIACs] closed to accrual effective 11/17/2003; only open for patients receiving non-EIACs). A total of 93 patients will be accrued for phase II (only open for patients receiving EIACs; not open yet for patients receiving non-EIACs) within approximately 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed grade IV astrocytoma or gliosarcoma - No oligodendrogliomas/oligoastrocytomas - Study entry must occur within 8 weeks after surgery PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count 1,500/mm^3 - Platelet count 130,000/mm^3 Hepatic: - Bilirubin 1.5 times upper limit of normal (ULN) - SGOT 2 times ULN Renal: - Creatinine 0.5 mg/dL above ULN Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection - No other concurrent malignant disease except superficial skin cancers - No other major medical problems PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for any tumor Surgery: - See Disease Characteristics Other: - Phase II (only open for patients receiving enzyme-inducing anticonvulsants (EIACs); not open yet for patients receiving non-EIACs): - Concurrent enzyme-inducing anticonvulsants (phenytoin, phenobarbital, or carbamazepine) allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KurtJaeckle, Study Chair, Mayo Clinic
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Kurt Jaeckle 904-953-7102
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Additional Information:
Study ID Numbers: CDR0000069048; NCCTG-N997D
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027612
Other Adult Glioblastoma Multiforme Studies:
1. Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
2. Carmustine in Treating Patients With Recurrent Malignant Glioma
3. Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
4. Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
5. Bortezomib in Treating Patients With Recurrent Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Illinois Clinical Trials
Other Peoria Clinical Trials
Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
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