Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors

NCT00313521 | Unknown Phase 2

• 4 other identifiers: CDR0000454503CCLG-9405EU-20575CCLG-CNS-1995-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well thiotepa works together with radiation therapy in treating young patients with newly diagnosed malignant brain tumors.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood cerebellar astrocytoma; childhood high-grade cerebral astrocytoma

Outcome Measures

Primary Outcomes (1)

• Degree of surgical resection by surgical and radiological assessments

Secondary Outcomes (1)

• Tumor response to chemotherapy by imaging

Interventions

thiotepa DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following high-grade (malignant) astrocytic tumors: * Anaplastic astrocytoma * Glioblastoma * Giant cell glioblastoma * Gliosarcoma * Any anatomical site except brain stem * Newly diagnosed disease * Has undergone tumor biopsy or surgical resection within the past 2 weeks * Patients with post-operative residual disease (grade III or IV) are eligible * Post-operative imaging of tumor within 72 hours of surgery * Patients with no imageable post-operative disease are not eligible * No neurological deterioration within 3 days of study treatment * Increasing requirement for steroids to control symptoms of intracranial pressure is considered evidence of neurological deterioration PATIENT CHARACTERISTICS: * Lansky play score 40-100% * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Creatinine ≥ 1.5 times upper limit of normal PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or radiotherapy

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

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma

Interventions

Thiotepa; Chemotherapy, Adjuvant; 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)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• David A. Walker

  Queen's Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 12, 2006
• Study Start: June 1, 1995
• Primary Completion: November 1, 1997
• Last Updated: September 20, 2013

Record last verified: 2006-12