Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery

Back to results

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 medulloblastoma

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven medulloblastoma The following variants of medulloblastoma are also eligible: Nodular/desmoplastic medulloblastoma Medullomyoblastoma Melanotic medulloblastoma Metastatic disease, meeting at least 1 of the following criteria: Unequivocal evidence on pre- or post-operative MR scan of supratentorial (stage M2) metastases and/or spinal metastases (stage M3) Tumor cells seen on cytospin analysis of lumbar cerebral spinal fluid (CSF) (stage M1) performed between 15 days and 21 days after surgery Involvement of CSF pathways by tumor is defined as the unequivocal identification of primitive neuroectodermal cells, either on cytological grounds or with a combination of cytological and immunocytological features (e.g., reactivity for GFAP or a neuronal marker, such as synaptophysin) Underwent surgery to remove the tumor no more than 6 weeks ago PATIENT CHARACTERISTICS: 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 (1-16 years) or Karnofsky (>16 years) performance status 30-100% No active infection No prior malignant disease Not pregnant or nursing No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility Not require anesthesia No hearing loss or renal impairment that would make the patient unable to comply with 'Packer' chemotherapy protocol PRIOR CONCURRENT THERAPY: No steroids, if possible, at the start of radiotherapy OR on a stable or reducing dose of steroids during the week before starting radiotherapy No prior chemotherapy or radiotherapy Dexamethasone should not be used as an anti-emetic unless other therapies fail

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
Cookridge 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

Secondary Outcome Measures

Full Information

NCT ID

NCT00276666

First Posted

January 12, 2006

Last Updated

September 16, 2013

Sponsor

Children's Cancer and Leukaemia Group

1. Study Identification

Unique Protocol Identification Number

NCT00276666

Brief Title

Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery

Official Title

Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2001 (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, vincristine, and cisplatin, 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 together with combination chemotherapy after surgery may kill any tumor cells that remain. PURPOSE: This phase II trial is studying giving radiation therapy together with combination chemotherapy to see how well it works in treating young patients with metastatic medulloblastoma who have undergone surgery.

Detailed Description

OBJECTIVES: Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in young patients with metastatic medulloblastoma. Determine the toxicity of chemotherapy (vincristine during radiotherapy and 8 courses of lomustine, cisplatin, and vincristine after radiotherapy) in association with HART in these patients. OUTLINE: This is a multicenter study. Radiotherapy and vincristine: Beginning 4-6 weeks after surgery, patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks. Patients also receive vincristine IV once weekly for 8 weeks beginning in week 1*. Approximately 6-8 weeks after completion of radiotherapy, patients proceed to maintenance chemotherapy. NOTE: *The first 7 patients undergo radiotherapy without receiving vincristine Maintenance chemotherapy: Patients receive oral lomustine once on day 1 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 5 years. PROJECTED ACCRUAL: A total of 29 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 medulloblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

29 (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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven medulloblastoma The following variants of medulloblastoma are also eligible: Nodular/desmoplastic medulloblastoma Medullomyoblastoma Melanotic medulloblastoma Metastatic disease, meeting at least 1 of the following criteria: Unequivocal evidence on pre- or post-operative MR scan of supratentorial (stage M2) metastases and/or spinal metastases (stage M3) Tumor cells seen on cytospin analysis of lumbar cerebral spinal fluid (CSF) (stage M1) performed between 15 days and 21 days after surgery Involvement of CSF pathways by tumor is defined as the unequivocal identification of primitive neuroectodermal cells, either on cytological grounds or with a combination of cytological and immunocytological features (e.g., reactivity for GFAP or a neuronal marker, such as synaptophysin) Underwent surgery to remove the tumor no more than 6 weeks ago PATIENT CHARACTERISTICS: 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 (1-16 years) or Karnofsky (>16 years) performance status 30-100% No active infection No prior malignant disease Not pregnant or nursing No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility Not require anesthesia No hearing loss or renal impairment that would make the patient unable to comply with 'Packer' chemotherapy protocol PRIOR CONCURRENT THERAPY: No steroids, if possible, at the start of radiotherapy OR on a stable or reducing dose of steroids during the week before starting radiotherapy No prior chemotherapy or radiotherapy Dexamethasone should not be used as an anti-emetic unless other therapies fail

Overall Study Officials: