Status:
COMPLETED
Combination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
5-55 years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, busulfan, and O6-benzylguanine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them f...
Detailed Description
OBJECTIVES: Primary * Determine the safety and feasibility of a conditioning regimen comprising temozolomide, radiotherapy, and busulfan followed by an infusion of autologous stem cells genetically ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed high-grade glioma of 1 of the following types:
- Glioblastoma multiforme
- WHO grade IV disease
- Anaplastic astrocytoma
- WHO grade III disease
- No low-grade disease (i.e., WHO grade I-II disease)
- No WHO grade III oligodendroglioma or oligoastrocytoma
- Patients \> 30 years of age who have undergone a gross total resection and have nonmeasurable disease as seen on postoperative MRI are eligible
- Measurable disease, as assessed by postoperative MRI, is required in patients ≤ 30 years of age
- No tumor arising in the spine or brainstem
- No metastatic disease in the spine
- PATIENT CHARACTERISTICS:
- Age
- 5 to 55
- Performance status
- Karnofsky 50-100% (for patients 11-30 years of age) OR
- Lansky 50-100% (for patients 5-10 years of age)
- Life expectancy
- At least 9 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 75,000/mm\^3 (transfusion independent)
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- ALT and AST ≤ 2.5 times upper limit of normal
- Albumin ≥ 2.0 g/dL
- Hepatitis B surface antigen and core antibody negative
- Hepatitis C antibody negative
- Renal
- Creatinine normal OR
- Glomerular filtration rate ≥ 70 mL/min
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Neurologic deficits must be stable or decreasing
- No active infection
- HIV negative
- No other serious illness or medical condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- No prior chemotherapy
- Endocrine therapy
- Concurrent corticosteroids allowed provided dose is stable or decreasing
- Radiotherapy
- No prior radiotherapy
- Surgery
- See Disease Characteristics
- Other
- No other concurrent investigational anticancer agents
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00253487
Start Date
August 1 2005
End Date
August 1 2012
Last Update
January 6 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.