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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00313521
First received: April 11, 2006
Last updated: September 19, 2013
Last verified: December 2006
  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
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Estimated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00313521     History of Changes
Other Study ID Numbers: CDR0000454503, CCLG-9405, EU-20575, CCLG-CNS-1995-01
Study First Received: April 11, 2006
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood cerebellar astrocytoma
childhood high-grade cerebral astrocytoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Thiotepa
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014