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Brain and Central Nervous System TumorsPhase 2NCT00047177

Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

A Phase 2 study testing Oxaliplatin in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 10 sites in United States.

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. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or atypical teratoid… Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
Oxaliplatin
How many people
43 participants
Where
10 sitesUnited States
Study dates
Oct 2002to Jul 2007
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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed medulloblastoma, supratentorial primitive neuroectodermal tumor (including pineoblastomas and ependymoblastomas), or atypical teratoid rhabdoid tumor
  • Recurrent or refractory disease
  • Measurable disease by radiography
  • Patients with positive cerebrospinal fluid cytology or linear leptomeningeal disease are eligible

PATIENT CHARACTERISTICS:

Age

  • 21 and under

Performance status

  • Karnofsky 50-100% OR
  • Lansky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3 (transfusion independent)
  • Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • ALT less than 2.5 times normal

Renal

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction at least 50% by MUGA

Pulmonary

  • No dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry greater than 94%

Other

  • No uncontrolled infection
  • No active graft-versus-host disease
  • No uncontrolled seizure disorders
  • Seizure disorders well controlled with anticonvulsants allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 2 weeks since prior growth factors
  • At least 6 months since prior allogeneic stem cell transplantation
  • No concurrent colony-stimulating factors during the first course of study
  • No concurrent immunomodulating agents

Chemotherapy

  • At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas) and recovered
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • If concurrent corticosteroids necessary for intracranial pressure, must be on stable or decreasing dose for at least 1 week prior to study
  • No other concurrent corticosteroids

Radiotherapy

  • At least 2 weeks since prior local palliative radiotherapy (small port) to symptomatic metastatic sites
  • At least 3 months since prior craniospinal radiotherapy
  • No concurrent palliative radiotherapy
  • Recovered from prior radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent anticancer or experimental drugs

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Texas Children's Cancer Center

    Houston, Texas, 77030-2399

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

About this study

Official title: A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor.

Read the detailed description

OBJECTIVES:

  • Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at first progression.
  • Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at second or later relapse.
  • Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
  • Describe the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (medulloblastoma [measurable disease at first relapse vs positive cerebrospinal fluid or linear leptomeningeal disease vs measurable disease at second or later progression] vs supratentorial primitive neuroectodermal tumor vs atypical teratoid rhabdoid tumor).

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 1.5-2.8 years.

Being tested
Oxaliplatin
Keywords
recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood ependymoma, childhood atypical teratoid/rhabdoid tumor
Medical subject headings
Central Nervous System Neoplasms, Medulloblastoma, Familial ependymoma, Rhabdoid Tumor

What participants receive

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression

  2. Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse

Secondary outcomes (2)

  1. Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT)

  2. Pharmacokinetics of oxaliplatin in the serum and CSF

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 startOct 2002
  3. Primary completionAug 2004
  4. Study completionJul 2007

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
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047177
Sponsor's protocol ID
CDR0000257562
Other IDs
PBTC-010
Status last verified
Oct 2009
First submitted
3 Oct 2002
Last updated
15 Oct 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Fouladi M, Blaney SM, Poussaint TY, Freeman BB 3rd, McLendon R, Fuller C, Adesina AM, Hancock ML, Danks MK, Stewart C, Boyett JM, Gajjar A. Phase II study of oxaliplatin in children with recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal tumors, and atypical teratoid rhabdoid tumors: a pediatric brain tumor consortium study. Cancer. 2006 Nov 1;107(9):2291-7. doi: 10.1002/cncr.22241.

    PubMed 17019740

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 10 sites in United States.

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 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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.

What does the primary outcome measure?

Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00047177, 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 15 Oct 2009.

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