Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00003288
Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
A Phase 1 study testing filgrastim, cyclophosphamide and tirapazamine in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 28 sites in 2 countries.
Trial summary
Phase I trial to study the effectiveness of tirapazamine plus cyclophosphamide in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- filgrastim, cyclophosphamide and tirapazamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Aug 1998to Jun 2003
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor that is refractory to conventional therapy or for which no effective therapy is known
- Brain tumors eligible Brainstem gliomas may waive histological verification requirement
- Neurologic deficits associated with CNS malignancies must be stable for a minimum of 4 weeks prior to study
- No leukemia Stratum 2
- No marrow involvement
PATIENT CHARACTERISTICS:
- Age: 21 and under
- Performance status: Karnofsky or Lansky 50-100%
- Life expectancy: At least 8 weeks
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 75,000/mm3
- Hemoglobin at least 9 g/dL
- Bilirubin less than 1.5 mg/dL
- SGPT less than 5 times normal
- Creatinine normal for age OR creatinine clearance at least 70 mL/min
- Shortening fraction at least 27% of normal OR ejection fraction greater than 50% of normal
- Not pregnant or nursing
- Negative pregnancy test required
PRIOR CONCURRENT THERAPY:
- No concurrent anticancer therapy
- At least 6 months since bone marrow transplant and no evidence of graft versus host disease
- At least 1 week since growth factors
- No concurrent granulocyte colony-stimulating factor
- Recovered from prior immunotherapy
- Stratum 2: No prior bone marrow transplantation (with or without total body irradiation)
- At least 6 weeks since prior nitrosourea
- At least 2 weeks since other prior myelosuppressive chemotherapy
- Dexamethasone must be a stable or decreasing dose for 2 weeks prior to study
- Recovered from prior chemotherapy
- Stratum 2: No more than 2 prior chemotherapy regimens
- At least 2 weeks since local palliative radiotherapy (small port)
- At least 6 months since prior substantial bone marrow radiation (e.g., cross- sectional radiotherapy [greater than 24 Gy], total body irradiation, hemi- pelvic radiotherapy)
- Recovered from prior radiotherapy
- Stratum 2: No prior central axis radiation
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States25 sites
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
Floating Hospital for Children
Boston, Massachusetts, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Children's Hospital of Michigan
Detroit, Michigan, 48201
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Baylor College of Medicine
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Washington University School of Medicine
St Louis, Missouri, 63110
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Canada3 sites
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: A Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors
Phase I trial to study the effectiveness of tirapazamine plus cyclophosphamide in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the dose limiting toxicity of tirapazamine when administered with cyclophosphamide as intravenous infusions to children with refractory solid tumors.
II. Determine the incidence and severity of other toxicities of tirapazamine and cyclophosphamide in these patients.
III. Determine a safe and tolerable dose of tirapazamine administered with cyclophosphamide for a phase II study for the same indications.
IV. Determine the pharmacokinetics of tirapazamine in children and adolescents receiving the combination of tirapazamine and cyclophosphamide.
- Determine the preliminary evidence of antitumor activity of tirapazamine and cyclophosphamide.
OUTLINE: This is a dose escalation study.
Patients receive tirapazamine by 2 hour intravenous infusion (hours 0-2) followed 2 hours later by a 30 minute intravenous infusion of cyclophosphamide. This course is repeated every 3 weeks in patients with partial/complete response or stable disease for a maximum of 1 year. Cohorts of 3-6 patients each are treated at each dose level of tirapazamine. Dose escalation of tirapazamine occurs when 0 of 3 patients or 1 of 6 patients has experienced dose limiting toxicity (DLT). If DLT is experienced in 1 of 3 patients at a given dose level, up to 3 additional patients are treated at that same dose level. If none of the 3 additional patients at that dose level experiences DLT, the dose is escalated. If DLT is experienced in 1 or more of the additional 3 patients, the maximum tolerated dose (MTD) has been exceeded and 3 patients are treated at the next lower dose level (defined as the MTD). A total of six patients are treated at the MTD. If DLT is proved to be neutropenia, patients must then also meet the additional eligibility criteria listed for stratum 2. If neutropenia continues to be the DLT in stratum 2, then additional patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning 24 hours after cyclophosphamide. A second MTD may be determined for chemotherapy with G-CSF. Patients are followed every 6 months for 4 years, and then annually thereafter.
- Being tested
- filgrastim, cyclophosphamide, tirapazamine
- 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
cyclophosphamideDrug
tirapazamineDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | See arm description. Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: tirapazamine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2004 (estimated)
- Study startAug 1998
- Primary completionJun 2003
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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Victor Aquino, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003288
- Sponsor's protocol ID
- NCI-2012-01837
- Other IDs
- POG-9675, CDR0000066219
- Status last verified
- Apr 2000
- First submitted
- 1 Nov 1999
- Last updated
- 5 Feb 2013
- Results posted
- No
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 Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00003288
- Acronym / sponsor ID
- NCI-2012-01837
- Keywords
- unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 1998
- Primary completion
- Jun 2003 (actual)
- First posted
- 13 Sep 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 I trial to study the effectiveness of tirapazamine plus cyclophosphamide in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the dose limiting toxicity of tirapazamine when administered with cyclophosphamide as intravenous infusions to children with refractory solid tumors.
II. Determine the incidence and severity of other toxicities of tirapazamine and cyclophosphamide in these patients.
III. Determine a safe and tolerable dose of tirapazamine administered with cyclophosphamide for a phase II study for the same indications.
IV. Determine the pharmacokinetics of tirapazamine in children and adolescents receiving the combination of tirapazamine and cyclophosphamide.
- Determine the preliminary evidence of antitumor activity of tirapazamine and cyclophosphamide.
OUTLINE: This is a dose escalation study.
Patients receive tirapazamine by 2 hour intravenous infusion (hours 0-2) followed 2 hours later by a 30 minute intravenous infusion of cyclophosphamide. This course is repeated every 3 weeks in patients with partial/complete response or stable disease for a maximum of 1 year. Cohorts of 3-6 patients each are treated at each dose level of tirapazamine. Dose escalation of tirapazamine occurs when 0 of 3 patients or 1 of 6 patients has experienced dose limiting toxicity (DLT). If DLT is experienced in 1 of 3 patients at a given dose level, up to 3 additional patients are treated at that same dose level. If none of the 3 additional patients at that dose level experiences DLT, the dose is escalated. If DLT is experienced in 1 or more of the additional 3 patients, the maximum tolerated dose (MTD) has been exceeded and 3 patients are treated at the next lower dose level (defined as the MTD). A total of six patients are treated at the MTD. If DLT is proved to be neutropenia, patients must then also meet the additional eligibility criteria listed for stratum 2. If neutropenia continues to be the DLT in stratum 2, then additional patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning 24 hours after cyclophosphamide. A second MTD may be determined for chemotherapy with G-CSF. Patients are followed every 6 months for 4 years, and then annually thereafter.
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: cyclophosphamide, Drug: tirapazamineSee arm description. |
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 |
| cyclophosphamide | Drug | Arm I |
| tirapazamine | 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.
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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.
Victor Aquino, MD study chair
Simmons Cancer Center
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing filgrastim, cyclophosphamide and tirapazamine in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 28 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 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 28 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 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 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?
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; AzTrials last refreshed its copy on 1 Nov 2026.