Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma
Recruitment status was Recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | SIOP Study of Combined Modality Treatment in Childhood Ependymoma |
- Event-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Surgical operability [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 65 |
| Study Start Date: | January 1999 |
OBJECTIVES:
- Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy.
- Determine the response rate in these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy.
Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended.
Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery.
Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.
Eligibility| Ages Eligible for Study: | 3 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven nonmetastatic intracranial ependymoma
- Cellular
- Papillary
- Clear cell
- Mixed cell
- Anaplastic
- No myxopapillary ependymoma, subependymoma, or ependymoblastoma
PATIENT CHARACTERISTICS:
Age:
- 3 to 20
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- No hematologic disease that would preclude study participation
Hepatic:
- Not specified
Renal:
- No renal disease that would preclude study participation
Other:
- No concurrent unrelated disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior steroids allowed
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Contacts and Locations| Argentina | |
| Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia | Recruiting |
| Buenos Aires, Argentina, 1428 | |
| Contact: Blanca D. Diez, MD 54-11-5777-3200 bdiez@fleni.org.ar | |
| Canada, Ontario | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Eric Bouffet, MD, MRCP 416-813-7457 eric.bouffet@sickkids.ca | |
| Italy | |
| Fondazione Istituto Nazionale dei Tumori | Recruiting |
| Milan, Italy, 20133 | |
| Contact: Maura Massimino, MD 39-02-239-02-593 maura.massimino@istitutotumori.mi.it | |
| Netherlands | |
| Erasmus MC - Sophia Children's Hospital | Recruiting |
| Rotterdam, Netherlands, 3015 GJ | |
| Contact: R. Reddingius, MD, PhD 31-10-463-6363 | |
| Spain | |
| Hospital Des Cruces | Recruiting |
| Vizcaya, Spain, 48 | |
| Contact: Aurora Navajas 34-94-600-6000 | |
| Sweden | |
| Ostra Sjukhuset | Recruiting |
| Gothenburg, Sweden, 41685 | |
| Contact: Brigitta Lannering, MD, PhD 46-31-343-5224 | |
| United Kingdom | |
| Birmingham Children's Hospital | Recruiting |
| Birmingham, England, United Kingdom, B4 6NH | |
| Contact: Richard Grundy, MD, PhD 44-121-333-8234 richard.grundy@nottingham.ac.uk | |
| Study Chair: | Richard Grundy, MD, PhD | Birmingham Children's Hospital |
| Study Chair: | Maura Massimino, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004224 History of Changes |
| Other Study ID Numbers: | CDR0000067465, SIOP-EPENDYMOMA-99, AIEOP-EPENDYMOMA-99, CCLG-EPENDYMOMA-99, EU-99001 |
| Study First Received: | January 28, 2000 |
| Last Updated: | August 7, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
childhood infratentorial ependymoma childhood supratentorial ependymoma newly diagnosed childhood ependymoma |
Additional relevant MeSH terms:
|
Ependymoma Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Cyclophosphamide Etoposide |
Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 16, 2013