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Home > "E" Clinical Trials Conditions > Erlotinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme  Erlotinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Erlotinib and Radiation Therapy 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Combining erlotinib with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and radiation therapy in treating patients who have glioblastoma multiforme.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib administered with radiotherapy in patients with glioblastoma multiforme. - Determine the safety and tolerability of this regimen in these patients. - Determine the toxic effects of this regimen in these patients. - Determine the efficacy of this regimen, in terms of survival, of these patients. - Determine the response rate and time to progression in patients treated with this regimen. - Determine the 6-month progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients are stratified according to concurrent enzyme-inducing anticonvulsant drug use (yes vs no). - Patients receive oral erlotinib once daily. After 1 week of erlotinib alone, patients also receive concurrent radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Once the MTD of erlotinib is determined, additional patients are treated with erlotinib at the MTD and radiotherapy as above. Patients are followed every 2 months for 1 year, every 3 months for 1 year, at least every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 12-60 patients (6-18 not receiving concurrent enzyme-inducing anticonvulsant drugs [EIADs] and 6-42 receiving concurrent EIADs) will be accrued for the phase I portion of this study within 4-12 months. A total of 93 patients will be accrued for the phase II portion of this study within 11 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed glioblastoma multiforme - Gliosarcomas allowed - Must be enrolled at least 1 week, but no more than 4 weeks, after prior biopsy or surgery PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 6 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal: - No inability to take oral medications - No requirement for IV alimentation - No active uncontrolled peptic ulcer disease Ophthalmic: - No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Other: - No other active malignancy requiring treatment - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for any brain tumor Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for any brain tumor Surgery: - See Disease Characteristics - More than 21 days since prior major surgery (excluding neurosurgical biopsy or brain tumor resection) - No prior surgical procedures affecting absorption Other: - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent warfarin - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulBrown, Study Chair, Mayo Clinic Cancer Center
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
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 Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Paul Brown 507-284-2511
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
Additional Information:
Study ID Numbers: CDR0000069388; NCCTG-N0177
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039494
Other Adult Glioblastoma Multiforme Studies:
1. Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma
2. Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
3. Temozolomide in Treating Patients With Recurrent Malignant Glioma
4. Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
5. Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Iowa Clinical Trials
Other Sioux City Clinical Trials
Erlotinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
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