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AzTrials

Brain and Central Nervous System TumorsPhase 2NCT00006258

Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

A Phase 2 study testing filgrastim, cisplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors, run by Children's Hospital Los Angeles at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 or combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study

Who is it for?
Ages 10 to 65 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
filgrastim, cisplatin and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
Not given
Where
3 sitesin 2 countries
Study dates
Nov 1997to Jan 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histological confirmation of one of the following:
  • High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or greater)
  • Primitive neuroectodermal tumor
  • Ependymoma
  • Incompletely resected on postoperative MRI or neurosurgical report
  • Definitive prior surgery within 42 days of study

PATIENT CHARACTERISTICS:

Age:

  • 10 to 65

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGPT less than 2.5 times upper limit of normal

Renal:

  • Creatinine clearance greater than 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed
  • No concurrent corticosteroids as antiemetics

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

Other trials in United States

Canada1 site

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

Other trials in Canada

About this study

Official title: Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemotherapy Regimen Followed by Standard Irradiation

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 or combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected, newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.

Read the detailed description

OBJECTIVES:

  • Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin, vincristine, cyclophosphamide, and etoposide with or without methotrexate followed by standard radiotherapy in patients with surgically resected, newly diagnosed high stage medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.
  • Determine the response rate, time to progression, overall survival, and pattern of failure in these patients treated with this regimen.

OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day 3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of chemotherapy.

Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.

Keywords
childhood infratentorial ependymoma, childhood supratentorial ependymoma, adult medulloblastoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult ependymoblastoma, untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood medulloblastoma, newly diagnosed childhood ependymoma, adult supratentorial primitive neuroectodermal tumor (PNET)
Medical subject headings
Central Nervous System Neoplasms, Medulloblastoma, Ependymoma, Neuroectodermal Tumors, Primitive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1997
  3. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006258
Sponsor's protocol ID
CHLA-NYU-0002H
Other IDs
CDR0000068192, NYU-0027H, NCI-G00-1852
Status last verified
Dec 2004
First submitted
11 Sep 2000
Last updated
18 Jul 2013
Results posted
No

Publications

  • Dhodapkar K, Dunkel IJ, Gardner S, Sapp M, Thoron L, Finlay J. Preliminary results of dose intensive pre-irradiation chemotherapy in patients older than 10 years of age with high risk medulloblastoma and supratentorial primitive neuroectodermal tumors. Med Pediatr Oncol. 2002 Jan;38(1):47-8. doi: 10.1002/mpo.1262. No abstract available.

    PubMed 11835236

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, cisplatin and cyclophosphamide in people with Brain and Central Nervous System Tumors, run by Children's Hospital Los Angeles at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006258, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.

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