Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors - Full Text View

Sponsored by:	Children's Cancer and Leukaemia Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00313521

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: thiotepa Procedure: adjuvant therapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

Drug Information available for: Thiotepa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Continuous Infusion Thiotepa in High Grade Astrocytic Tumors of Childhood and Adolescence A UKCCSG Phase II Study Involving the Brain Tumour and New Agent Groups

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Degree of surgical resection by surgical and radiological assessments [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor response to chemotherapy by imaging [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 1995
Primary Completion Date:	November 1997 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	3 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313521

Sponsors and Collaborators

Children's Cancer and Leukaemia Group

Investigators

Study Chair:

David A. Walker

Queen's Medical Centre

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000454503, CCLG-9405, EU-20575, CCLG-CNS-1995-01
Study First Received:	April 11, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00313521
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated childhood cerebellar astrocytoma
childhood high-grade cerebral astrocytoma

Study placed in the following topic categories:

Brain Neoplasms
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms

Brain Diseases
Nervous System Neoplasms
Thiotepa

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009