Brain and Central Nervous System TumorsPhase 2NCT00002825
Docetaxel in Treating Children With Recurrent Solid Tumors
A Phase 2 study testing filgrastim and docetaxel in people with Brain and Central Nervous System Tumors and Neuroblastoma, run by National Cancer Institute (NCI) at 36 sites in 3 countries.
Trial summary
Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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, Neuroblastoma, Sarcoma
- What is being tested?
- filgrastim and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 36 sitesin 3 countries
- Study dates
- Jan 1997to Dec 2004
- 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 verified (at original diagnosis) solid tumor that is relapsed or refractory The following histologies are eligible:
- Sarcomas: Rhabdomyosarcoma Ewing's sarcoma, Peripheral neuroectodermal tumor (PNET), Osteosarcoma, Other soft tissue sarcomas
- Brain tumors: Ependymoma Primitive neuroectodermal tumor (PNET), High grade astrocytoma, Brain stem glioma (histologic verification not required), Neuroblastoma
- Measurable disease that can be followed clinically or radiologically required
- The following not considered measurable: Bone lesions measured by bone scan or bone marrow involvement
- Central nervous system disease documented by cerebrospinal fluid cytology
- Pleural effusion
PATIENT CHARACTERISTICS:
- Age: 21 and under at original diagnosis
- Performance status: 0-3
- Life expectancy: Greater than 2 months
- In the absence of marrow involvement:
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 100,000/mm3 (transfusion independent)
- Hemoglobin at least 9.0 g/dL (transfusion allowed)
- With bone marrow involvement:
- Absolute neutrophil count at least 750/mm3
- Red cell and platelet support possible
- Bilirubin normal
- ALT/AST less than 1.5 times normal
- Alkaline phosphatase less than 2.5 times normal
- Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min
- Not pregnant or nursing
- Adequate contraception required of fertile women
PRIOR CONCURRENT THERAPY:
- Prior bone marrow transplantation allowed:
- Must have stable engraftment without need for significant blood product support or cytokine therapy
- No concurrent immunomodulating agents
- No prior paclitaxel or docetaxel At least 2 weeks since chemotherapy (4 weeks since nitrosoureas)
- No other concurrent cancer chemotherapy
- Concurrent corticosteroids allowed for intracranial pressure in brain tumor patients provided patient has been stable for at least 4 weeks
- Corticosteroids allowed as pretreatment for docetaxel
- At least 2 months since extensive radiotherapy, defined as:
- Craniospinal Volume greater than 50% of abdominopelvic cavity
- Volume greater than one third of lung volume
- No concurrent radiotherapy
- No more than 2 prior therapies and fully recovered
Trial locations and contacts
36 sites in 3 countries.
36 sites in 3 countries
United States33 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
Children's Hospital of Denver
Denver, Colorado, 80218
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
Children's Mercy Hospital
Kansas City, Missouri, 64108
Long Beach Memorial Medical Center
Long Beach, California, 90806
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
Children's Hospital of Orange County
Orange, California, 92868
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Kaiser Permanente Medical Center-Sacramento
Sacramento, California, 95825
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Canada2 sites
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS
Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Read the detailed description
OBJECTIVES:
- Determine the response rate to docetaxel in children with recurrent sarcomas, neuroblastomas, or brain tumors.
II. Describe the toxic effects of docetaxel in these patients.
OUTLINE:
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. Patients are followed for survival.
- Being tested
- filgrastim, docetaxel
- Keywords
- recurrent childhood rhabdomyosarcoma, recurrent neuroblastoma, recurrent osteosarcoma, recurrent childhood soft tissue sarcoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma
- Medical subject headings
- Central Nervous System Neoplasms, Neuroblastoma, Sarcoma, Osteosarcoma, Astrocytoma, Medulloblastoma, Neuroectodermal Tumors, Primitive, Peripheral, Familial ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
docetaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. Receives: Biological: filgrastim; Drug: docetaxel |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2004 (estimated)
- Study startJan 1997
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Theodore Zwerdling, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002825
- Sponsor's protocol ID
- NCI-2012-02247
- Other IDs
- CCG-0962, CDR0000065008
- Status last verified
- May 2006
- First submitted
- 1 Nov 1999
- Last updated
- 5 Feb 2013
- Results posted
- No
Publications
Blaney SM, Seibel NL, O'Brien M, Reaman GH, Berg SL, Adamson PC, Poplack DG, Krailo MD, Mosher R, Balis FM. Phase I trial of docetaxel administered as a 1-hour infusion in children with refractory solid tumors: a collaborative pediatric branch, National Cancer Institute and Children's Cancer Group trial. J Clin Oncol. 1997 Apr;15(4):1538-43. doi: 10.1200/JCO.1997.15.4.1538.
PubMed 9193350Zwerdling T, Krailo M, Monteleone P, Byrd R, Sato J, Dunaway R, Seibel N, Chen Z, Strain J, Reaman G; Children's Oncology Group. Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors: a report from the Children's Oncology Group. Cancer. 2006 Apr 15;106(8):1821-8. doi: 10.1002/cncr.21779.
PubMed 16532433
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS
- ClinicalTrials.gov ID
- NCT00002825
- Acronym / sponsor ID
- NCI-2012-02247
- Keywords
- recurrent childhood rhabdomyosarcoma, recurrent neuroblastoma, recurrent osteosarcoma, recurrent childhood soft tissue sarcoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 1997
- Primary completion
- Dec 2004 (actual)
- First posted
- 1 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES:
- Determine the response rate to docetaxel in children with recurrent sarcomas, neuroblastomas, or brain tumors.
II. Describe the toxic effects of docetaxel in these patients.
OUTLINE:
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. Patients are followed for survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: filgrastim, Drug: docetaxelAll patients receive docetaxel with G-CSF every 21 days for up to 12 courses. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | Arm I |
| docetaxel | Drug | Arm I |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Background: PubMed 9193350Blaney SM, Seibel NL, O'Brien M, Reaman GH, Berg SL, Adamson PC, Poplack DG, Krailo MD, Mosher R, Balis FM. Phase I trial of docetaxel administered as a 1-hour infusion in children with refractory solid tumors: a collaborative pediatric branch, National Cancer Institute and Children's Cancer Group trial. J Clin Oncol. 1997 Apr;15(4):1538-43. doi: 10.1200/JCO.1997.15.4.1538.
- Results publication: PubMed 16532433Zwerdling T, Krailo M, Monteleone P, Byrd R, Sato J, Dunaway R, Seibel N, Chen Z, Strain J, Reaman G; Children's Oncology Group. Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors: a report from the Children's Oncology Group. Cancer. 2006 Apr 15;106(8):1821-8. doi: 10.1002/cncr.21779.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Zwerdling, MD study chair
University of California, Davis
36 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim and docetaxel in people with Brain and Central Nervous System Tumors and Neuroblastoma, run by National Cancer Institute (NCI) at 36 sites in 3 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 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada, Australia. 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 NCT00002825, which also lists 2 linked publications.
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 5 Feb 2013.