Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

cisplatin

lomustine

vincristine sulfate

adjuvant therapy

radiation therapy

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring untreated childhood supratentorial primitive neuroectodermal tumor

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven nonpineal supratentorial primitive neuroectodermal tumors No supratentorial atypical teratoid/rhabdoid tumors or medulloepitheliomas Localized or metastatic disease Metastatic disease is defined as unequivocal evidence of supratentorial metastases and/or spinal metastases on pre-operative or postoperative MRI scan OR tumor cells seen on cytospin analysis of lumbar cerebrospinal fluid (stage M1) performed between 15 days and 21 days after surgery Has undergone surgical resection within the past 4-6 weeks PATIENT CHARACTERISTICS: Able to cooperate with twice daily fractions of radiotherapy Hemoglobin ≥ 10 g/dL Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Neurologically stable (or improving) during the week before starting radiotherapy Lansky performance status 30-100% (for patients 1 to 16 years of age) OR Karnofsky performance status 30-100% (for patients over 16 years of age) Must be able to comply with the chemotherapy protocol (e.g., no hearing loss, renal impairment) No presence of active uncontrolled infection No previous malignant disease Not pregnant or nursing No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility PRIOR CONCURRENT THERAPY: No previous chemotherapy or radiotherapy The patient should not be receiving steroids, if possible, at the start of radiotherapy or should be on a stable or reducing dose of steroids during the week before starting radiotherapy

Sites / Locations

Our Lady's Hospital for Sick Children Crumlin
Birmingham Children's Hospital
Institute of Child Health at University of Bristol
Addenbrooke's Hospital
Leeds Cancer Centre at St. James's University Hospital
Leicester Royal Infirmary
Royal Liverpool Children's Hospital, Alder Hey
Royal London Hospital
Great Ormond Street Hospital for Children
Royal Manchester Children's Hospital
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Queen's Medical Centre
Oxford Radcliffe Hospital
Children's Hospital - Sheffield
Southampton General Hospital
Royal Marsden - Surrey
Royal Belfast Hospital for Sick Children
Royal Aberdeen Children's Hospital
Royal Hospital for Sick Children
Royal Hospital for Sick Children
Childrens Hospital for Wales

Outcomes

Primary Outcome Measures

Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment

Secondary Outcome Measures

Overall and relapse free survival at follow up every 2 months for 1 year, every 3 months for 2 years, and then every 6 months for 2 years

Full Information

NCT ID

NCT00274911

First Posted

January 10, 2006

Last Updated

August 1, 2013

Sponsor

Children's Cancer and Leukaemia Group

1. Study Identification

Unique Protocol Identification Number

NCT00274911

Brief Title

Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors

Official Title

Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2004 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Children's Cancer and Leukaemia Group

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, cisplatin, and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy followed by combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving radiation therapy followed by combination chemotherapy works in treating young patients with supratentorial primitive neuroectodermal tumors.

Detailed Description

OBJECTIVES: Primary Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors. Secondary Determine overall and relapse-free survival of patients treated with HART followed by adjuvant combination chemotherapy comprising lomustine, cisplatin, and vincristine. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Radiotherapy: Patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks. Adjuvant combination chemotherapy: Six weeks after the last radiotherapy dose, patients receive oral lomustine once and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 . Treatment repeats every 6 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for at least 5 years. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

untreated childhood supratentorial primitive neuroectodermal tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

lomustine

Intervention Type

Drug

Intervention Name(s)

vincristine sulfate

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment

Secondary Outcome Measure Information:

Title

Overall and relapse free survival at follow up every 2 months for 1 year, every 3 months for 2 years, and then every 6 months for 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven nonpineal supratentorial primitive neuroectodermal tumors No supratentorial atypical teratoid/rhabdoid tumors or medulloepitheliomas Localized or metastatic disease Metastatic disease is defined as unequivocal evidence of supratentorial metastases and/or spinal metastases on pre-operative or postoperative MRI scan OR tumor cells seen on cytospin analysis of lumbar cerebrospinal fluid (stage M1) performed between 15 days and 21 days after surgery Has undergone surgical resection within the past 4-6 weeks PATIENT CHARACTERISTICS: Able to cooperate with twice daily fractions of radiotherapy Hemoglobin ≥ 10 g/dL Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Neurologically stable (or improving) during the week before starting radiotherapy Lansky performance status 30-100% (for patients 1 to 16 years of age) OR Karnofsky performance status 30-100% (for patients over 16 years of age) Must be able to comply with the chemotherapy protocol (e.g., no hearing loss, renal impairment) No presence of active uncontrolled infection No previous malignant disease Not pregnant or nursing No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility PRIOR CONCURRENT THERAPY: No previous chemotherapy or radiotherapy The patient should not be receiving steroids, if possible, at the start of radiotherapy or should be on a stable or reducing dose of steroids during the week before starting radiotherapy

Overall Study Officials: