Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00005844
Oxaliplatin in Treating Children With Advanced Solid Tumors
A Phase 1 study testing oxaliplatin in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by St. Jude Children's Research Hospital 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. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors. 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?
- oxaliplatin
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Sep 2007
- 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 metastatic or unresectable solid tumors that are not amenable to standard treatment
- Histological confirmation not required for brain stem tumors
- No known brain metastases
- No leukemia
PATIENT CHARACTERISTICS:
Age:
- 21 and under
Performance status:
- ECOG 0-2 OR
- Lansky 50-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3 (except with marrow involvement)
- Hemoglobin at least 8 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin 0.2-1.4 mg/dL
- AST/ALT no greater than 3 times upper limit of normal
Renal:
- Creatinine normal for age OR
- Creatinine clearance at least 50 mL/min
- Electrolytes, calcium, and phosphorus normal
Cardiovascular:
- No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No active graft-vs-host disease (GVHD)
- No allergy to platinum compounds or antiemetics
- No uncontrolled concurrent illness or infection
- No evidence of neuropathy
- Blood sugar normal
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior hematopoietic growth factors
- At least 3 months since prior stem cell transplantation and recovered
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea)
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 6 weeks since prior extensive radiotherapy to significant marrow-containing compartment
- At least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or extensive lung radiotherapy; or mantle and Y-port radiotherapy
- At least 6 months since prior total body irradiation
Surgery:
- Not specified
Other:
- No concurrent therapy for GVHD
- No other concurrent anticancer investigational or commercial agents
- No other concurrent anticancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
About this study
Official title: A Phase I Study of Oxaliplatin in Children With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors.
- Determine the toxic effects of this drug in these patients.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients.
- Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD for dose levels 1-4 is determined, an additional cohort of 3-6 patients is accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses).
PROJECTED ACCRUAL: Approximately 6-20 patients will be accrued for this study within 1-3.3 years.
- Being tested
- oxaliplatin
- 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.
oxaliplatinDrug
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 startApr 2000
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unspecified Childhood Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sheri L. Spunt, MD, Study chair, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005844
- Sponsor's protocol ID
- CDR0000067860
- Other IDs
- SJCRH-OXAL1, NCI-T99-0059
- Status last verified
- Oct 2012
- First submitted
- 2 Jun 2000
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Spunt SL, Freeman BB 3rd, Billups CA, McPherson V, Khan RB, Pratt CB, Stewart CF. Phase I clinical trial of oxaliplatin in children and adolescents with refractory solid tumors. J Clin Oncol. 2007 Jun 1;25(16):2274-80. doi: 10.1200/JCO.2006.08.2388.
PubMed 17538173Iacono LC, Spunt SL, Pratt CB, et al.: Pharmacokinetics of oxaliplatin in children with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2170, 89b, 2002.
Pratt CB, Spunt SL, Thompson SJ, et al.: Phase I Study of Oxaliplatin in Pediatric Patients with Malignant Solid Tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1498, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Oxaliplatin in Children With Solid Tumors
- ClinicalTrials.gov ID
- NCT00005844
- Acronym / sponsor ID
- CDR0000067860
- Keywords
- unspecified childhood solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2000
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (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.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors.
- Determine the toxic effects of this drug in these patients.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients.
- Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD for dose levels 1-4 is determined, an additional cohort of 3-6 patients is accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses).
PROJECTED ACCRUAL: Approximately 6-20 patients will be accrued for this study within 1-3.3 years.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| oxaliplatin | Drug | – |
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 23 Oct 2012.
- Results publication: PubMed 17538173Spunt SL, Freeman BB 3rd, Billups CA, McPherson V, Khan RB, Pratt CB, Stewart CF. Phase I clinical trial of oxaliplatin in children and adolescents with refractory solid tumors. J Clin Oncol. 2007 Jun 1;25(16):2274-80. doi: 10.1200/JCO.2006.08.2388.
- Results publicationIacono LC, Spunt SL, Pratt CB, et al.: Pharmacokinetics of oxaliplatin in children with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2170, 89b, 2002.
- Results publicationPratt CB, Spunt SL, Thompson SJ, et al.: Phase I Study of Oxaliplatin in Pediatric Patients with Malignant Solid Tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1498, 2001.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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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.
Sheri L. Spunt, MD study chair
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oxaliplatin in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by St. Jude Children's Research Hospital 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 23 Oct 2012. 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 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?
On the ClinicalTrials.gov record for NCT00005844, which also lists 3 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 23 Oct 2012.