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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00313521
Other study ID # CDR0000454503
Secondary ID CCLG-9405EU-2057
Status Active, not recruiting
Phase Phase 2
First received April 11, 2006
Last updated September 19, 2013
Start date June 1995

Study information

Verified date December 2006
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Description:

OBJECTIVES:

Primary

- Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric patients with newly diagnosed malignant astrocytic tumors.

Secondary

- Determine the acute and chronic toxicity of thiotepa in these patients.

- Determine the variability in thiotepa metabolism by measuring plasma and cerebrospinal fluid pharmacokinetics of thiotepa and tepa in these patients.

- Develop a phase II study framework model, to determine the chemosensitivity to new, single-agent regimens in the treatment of high-grade (malignant) astrocytic tumors, including anaplastic astrocytoma, glioblastoma, giant cell glioblastoma, and gliosarcoma.

- Determine the incidence of distant neuraxial metastases in patients at the time of relapse.

- Determine the 1-year disease-free survival rate in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by age (3-15 vs 16-20 years of age).

- Chemotherapy: Patients receive thiotepa IV continuously over 168 hours on days 1-7. Treatment repeats every 28 days for up to 2 courses. Patients then proceed to radiotherapy after blood counts recover.

- Radiotherapy: Patients undergo external-beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.

- Post-radiation chemotherapy: Patients with complete, partial, or objective response, or stable disease after 2 courses of thiotepa may receive thiotepa alone for up to 8 more courses at the discretion of the treating physician.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date
Est. primary completion date November 1997
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 20 Years
Eligibility 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

Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
thiotepa

Procedure:
adjuvant therapy

Radiation:
radiation therapy


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Children's Cancer and Leukaemia Group

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of surgical resection by surgical and radiological assessments No
Secondary Tumor response to chemotherapy by imaging No
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