Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: irinotecan hydrochloride Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme |
- Overall survival [ Designated as safety issue: No ]
- Short- and long-term toxicity [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
| Study Start Date: | November 2004 |
OBJECTIVES:
- Compare overall survival of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy and temozolomide followed by temozolomide and irinotecan with historical controls from the RTOG database.
- Determine the short- and long-term toxicity of this regimen in these patients.
- Determine progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7 days a week, for 6 weeks.
- Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision
- No gliomas graded less than glioblastoma multiforme
- No recurrent malignant gliomas
- No tumor foci below the tentorium or beyond the cranial vault
- Study therapy must begin ≤ 5 weeks after surgery
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- At least 8 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL*
- Hematocrit ≥ 30%* NOTE: *Transfusion allowed
Hepatic
- Bilirubin ≤ 0.5 mg/dL
- ALT or AST ≤ 2 times upper limit of normal
Renal
- Creatinine ≤ 1.5 mg/dL
- BUN ≤ 25 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception during and for 2 months after study participation
- No AIDS
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
- No other major medical illness or psychiatric impairment that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent sargramostim (GM-CSF)
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry
Radiotherapy
No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields
- Prior radiotherapy for stage T1 glottic cancer allowed
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan
- Concurrent non-enzyme-inducing antiepileptic drugs allowed
Contacts and Locations
Show 118 Study Locations| Study Chair: | Frank S. Lieberman, MD | University of Pittsburgh |
| Investigator: | Christina I. Tsien, MD | University of Michigan Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00099125 History of Changes |
| Other Study ID Numbers: | CDR0000389229, RTOG-0420 |
| Study First Received: | December 8, 2004 |
| Last Updated: | August 27, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult giant cell glioblastoma adult gliosarcoma adult glioblastoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide |
Dacarbazine Irinotecan Camptothecin Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013