Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00003194
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
A Phase 1 study testing filgrastim, carboplatin and cyclophosphamide in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Seattle Children's Hospital at 2 sites 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 1 year to 30 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- filgrastim, carboplatin and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1997to 19 Dec 2002
- Phase
- Phase 1
- 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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically proven recurrent or refractory pediatric solid tumor
- Bone marrow metastases allowed
PATIENT CHARACTERISTICS:
Age:
- 1 to 30
Performance status:
- 0-2
Life expectancy:
- At least 2 months
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 100,000/mm3 (transfusion independent)
- Hemoglobin at least 10 g/dL (RBC transfusion allowed)
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 2.5 times normal
Renal:
- Adequate renal function as defined by one of the following:
- GFR by creatinine clearance
- Radioisotope GFR
- Iothalamate at least 70 mL/min
Cardiovascular:
- Adequate cardiac function as defined by one of the following:
- Ejection fraction at least 55% by MUGA
- Fractional shortening at least 28% by echocardiogram
Neurologic:
- Adequate CNS function as defined by:
- Seizure disorder, if present, controlled by anticonvulsants
- CNS toxicity no greater than grade 2
Other:
- No uncontrolled infections
- Not pregnant or nursing
- No allergy to platinum compounds
- No history of allergy to etoposide (unless mobilization phase not required)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Recovered from prior immunotherapy
- At least 1 week since prior cytokines
- At least 3 months since prior bone marrow or peripheral blood stem cell transplantation
- No concurrent immunomodulator
- No concurrent cytokines
Chemotherapy:
- At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered
- No prior thiotepa
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Recovered from prior radiotherapy
- At least 6 months since prior total body irradiation conditioning
- No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow
Surgery:
- Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory 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: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of thiotepa.
Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection.
Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients receive 3 courses of therapy.
Cohorts of 3-6 patients receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 and 2 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued into this study.
- Being tested
- filgrastim, carboplatin, cyclophosphamide, etoposide, thiotepa
- Keywords
- unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
cyclophosphamideDrug
etoposideDrug
thiotepaDrug
topotecan hydrochlorideDrug
peripheral blood stem cell transplantationProcedure or surgery
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 startJul 1997
- Primary completion19 Dec 2002
- Study completion19 Dec 2002
Why it stopped: Study enrollment did not meet expected goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Primary purpose
- Treatment
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Doug Hawkins, Seattle Children's Hospital
- Investigators
- Douglas Hawkins, MD, Study chair, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003194
- Sponsor's protocol ID
- CHMC-6006
- Other IDs
- CDR0000066029, FHCRC-1244.00, NCI-G98-1373
- Status last verified
- Apr 2019
- First submitted
- 6 Apr 2000
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors.
- ClinicalTrials.gov ID
- NCT00003194
- Acronym / sponsor ID
- CHMC-6006
- Keywords
- unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment did not meet expected goals
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1997
- Primary completion
- 19 Dec 2002 (actual)
- Study completion
- 19 Dec 2002 (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: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of thiotepa.
Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection.
Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients receive 3 courses of therapy.
Cohorts of 3-6 patients receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 and 2 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued into this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 1 year to 30 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 | – |
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| etoposide | Drug | – |
| thiotepa | Drug | – |
| topotecan hydrochloride | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study enrollment did not meet expected goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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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.
Douglas Hawkins, MD study chair
Seattle Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing filgrastim, carboplatin and cyclophosphamide in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by Seattle Children's Hospital at 2 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: stopped early, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
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 was stopped early (reason given: Study enrollment did not meet expected goals). Results are not available in the source record.
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?
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 Apr 2019.