Brain and Central Nervous System TumorsPhase 1/2NCT00005952
Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors
A Phase 1/2 study testing filgrastim, temozolomide and peripheral blood stem cell transplantation in people with Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by Duke University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Head and Neck Cancer
- What is being tested?
- filgrastim, temozolomide and peripheral blood stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Nov 2005
- Phase
- Phase 1/2
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR
- Histologically confirmed non-CNS tumor
- Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma)
- Recurrent or resistant neuroblastoma
- Recurrent Wilm's tumor
- Recurrent Ewing's sarcoma
- Recurrent primitive neuroectodermal tumors
- Recurrent nasopharyngeal carcinoma
- Recurrent germ cell tumor
- Expected cure rate less than 10% with standard therapy
- Measurable and/or active disease
- History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and under
Performance status:
- Karnofsky 70-100% OR
- Lansky 70-100%
Life expectancy:
- Greater than 8 weeks
Hematopoietic:
- Reasonably cellular bone marrow (greater than 15% cellularity on biopsy)
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 75,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
- SGPT less than 120 U/L
Renal:
- Creatinine less than 1.5 mg/dL
Cardiovascular:
- Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram
Pulmonary:
- CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active infection
- Able to tolerate vigorous hydration schedule
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent white blood cell transfusion
- No other concurrent hematopoietic growth factors
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No other concurrent cytotoxic drugs (systemic or intrathecal)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 1 week since prior radiotherapy
Surgery:
- At least 1 week since prior surgery
Other:
- No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors.
- Evaluate the toxicity of this treatment in these patients.
- Determine the activity of this treatment in these patients.
OUTLINE: This is a dose escalation study of temozolomide.
Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months for 1-3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
- Conditions
- Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Neuroblastoma, Ovarian Cancer
- Being tested
- filgrastim, temozolomide, peripheral blood stem cell transplantation
- Keywords
- childhood low-grade cerebral astrocytoma, recurrent childhood rhabdomyosarcoma, childhood craniopharyngioma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage IV Wilms tumor, stage V Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors, childhood central nervous system germ cell tumor, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, stage IV nasopharyngeal cancer, recurrent nasopharyngeal cancer, childhood germ cell tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, childhood high-grade cerebral astrocytoma
- Medical subject headings
- Central Nervous System Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Neuroblastoma, Ovarian Neoplasms, Sarcoma, Testicular Germ Cell Tumor, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
temozolomideDrug
peripheral blood stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response at 12 months
Disease-free survival at 12 months
Secondary outcomes (2)
Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months
Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2000
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 1/2
- Primary purpose
- Treatment
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Henry S. Friedman, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005952
- Sponsor's protocol ID
- 1735
- Other IDs
- DUMC-1735-04-9R5, DUMC-1735-02-9R3, DUMC-1735-01-9R2, DUMC-1833-99-10, NCI-G00-1796, CDR0000067932
- Status last verified
- Feb 2013
- First submitted
- 5 Jul 2000
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT00005952
- Acronym / sponsor ID
- 1735
- Conditions
- Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Neuroblastoma, Ovarian Cancer
- Keywords
- childhood low-grade cerebral astrocytoma, recurrent childhood rhabdomyosarcoma, childhood craniopharyngioma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage IV Wilms tumor, stage V Wilms tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2000
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors.
- Evaluate the toxicity of this treatment in these patients.
- Determine the activity of this treatment in these patients.
OUTLINE: This is a dose escalation study of temozolomide.
Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months for 1-3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 18 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 | – |
| temozolomide | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Overall response at 12 months
Disease-free survival at 12 months
2 secondary outcomes
Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months
Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months
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 20 Jun 2013.
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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.
Henry S. Friedman, MD study chair
Duke Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing filgrastim, temozolomide and peripheral blood stem cell transplantation in people with Brain and Central Nervous System Tumors and Childhood Germ Cell Tumor, run by Duke University at 1 site 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Overall response at 12 months. 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?
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 20 Jun 2013.