Combination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas

NCT00253487 | Completed

• 3 other identifiers: CCHMC-04660CDR0000446082NCI-7036
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. O6-benzylguanine may also help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy with a peripheral stem cell transplant or bone marrow transplant, using stem cells from the patient that are genetically-modified in the laboratory to protect them from the side effects of chemotherapy, may allow more chemotherapy to be given so that more tumor cells are killed. Giving combination chemotherapy and radiation therapy together with a peripheral stem cell transplant or bone marrow transplant may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating younger patients who are undergoing an autologous stem cell transplant for newly diagnosed gliomas.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult anaplastic astrocytoma; childhood high-grade cerebral astrocytoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

O6-benzylguanine DRUG

busulfan DRUG

temozolomide DRUG

adjuvant therapy PROCEDURE

autologous bone marrow transplantation PROCEDURE

conventional surgery PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Astrocytoma; Gliosarcoma

Interventions

O(6)-benzylguanine; Busulfan; Temozolomide; Chemotherapy, Adjuvant; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative

Study Officials

• Lars M. Wagner, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 6, 2014

Record last verified: 2006-01