Childhood Central Nervous System ChoriocarcinomaPhase 1NCT00281944
Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors
A Phase 1 study testing oxaliplatin, fluorouracil and leucovorin calcium in people with Childhood Central Nervous System Choriocarcinoma and Childhood Central Nervous System Embryonal Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial is studying the side effects and best dose of oxaliplatin when given together with leucovorin and fluorouracil in treating young patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Embryonal Tumor, Childhood Central Nervous System Germ Cell Tumor
- What is being tested?
- oxaliplatin, fluorouracil and leucovorin calcium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2009
- 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
Who may be able to join
- Histologically diagnosed malignant solid tumor, including tumors of the CNS, that has progressed despite standard therapy or for which no effective standard therapy is known
- Patients with brainstem glioma or intrinsic pontine glioma do not need biopsy proof of the diagnosis if imaging studies are consistent with the diagnosis
- Measurable or nonmeasurable disease
- No pleural effusion or ascites causing respiratory compromise (≥ grade 2 dyspnea)
- ECOG performance status (PS) 0-2 for patients ≥ 16 years of age
- Karnofsky PS ≥ 40% for patients > 10 years of age
Show all 45Show fewer
- Lansky Play Scale ≥ 40% for patients ≤ 10 years of age
- Peripheral absolute neutrophil count (ANC) ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3 (transfusion independent)
- Hemoglobin ≥ 8.5 g/dL (transfusion permitted)
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Creatinine clearance OR radioisotope glomerular filtration rate > 60mL/min
- Total bilirubin < 1.5 mg/dL
- ALT and AST ≤ 2.5 times ULN (5 times ULN if liver involvement with primary tumor)
- Ejection fraction ≥ 50% OR shortening fraction ≥ 28%
- Life expectancy of > 8 weeks
- No radiological evidence of pulmonary fibrosis, interstitial pneumonia, or extensive and symptomatic interstitial fibrosis of the lung
- Room air oxygen saturation ≥ 90% at altitudes ≥ 5,000 feet OR ≥ 93% at altitudes < 5,000 feet
- DLCO > 50% of predicted (for patients who received prior bleomycin and are able to comply with pulmonary function testing)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to platinum or oxaliplatin as well as other agents used in study treatment
- No other serious or poorly controlled social circumstance, psychiatric illness, or medical condition including, but not limited to, the following: ongoing or active infection, uncontrolled seizure disorder, uncontrolled symptomatic congestive heart failure, or cardiac arrhythmia that could be exacerbated by or complicate compliance with study therapy
- No HIV-positive patients
- Recovered from prior therapy
- No persistent toxicities from previous therapies ≥ grade 2
- Stable grade 3 neurotoxicity is allowed in patients with CNS tumors only who have a baseline neurotoxicity due to primary tumor involvement or postoperative complications
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- At least 4 weeks since prior local radiotherapy (small port)
- At least 6 months since prior craniospinal irradiation, irradiation to ≥ 50% of the pelvis, or other substantial bone marrow irradiation, including total body irradiation
- No previous treatment with oxaliplatin
- At least 14 days since prior biological therapy (including monoclonalantibody therapy)
- At least 7 days since prior retinoids, sargramostim (GM-CSF), or filgrastim (G-CSF)
- At least 14 days since prior pegfilgrastim
- No concurrent pegfilgrastim or GM-CSF
- Patients requiring steroids should be on stable or decreasing dose for ≥ 7 days prior to study entry, and must not be on more than 4 mg of dexamethasone (or equivalent) per day
- At least 4 weeks since prior major surgical procedure
- Simple surgical procedures, including biopsy or central line placement or similar procedure, are allowed within 4 weeks of study entry if the patient has recovered to baseline
- At least 3 months since prior autologous or allogeneic stem cell transplantation
- No concurrent immunosuppressive therapy
- No evidence of ongoing graft versus host disease (GVHD)
- No concurrent use of other investigational agents
- No other concurrent anticancer therapies or agents
- No other concurrent chemotherapy, radiation therapy, or herbal medications or supplements
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Multi-Center Phase Ib Study of Oxaliplatin (NSC #266046) in Combination With Fluorouracil and Leucovorin in Pediatric Patients With Advanced Solid Tumors
This phase I trial is studying the side effects and best dose of oxaliplatin when given together with leucovorin and fluorouracil in treating young patients with advanced solid tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of oxaliplatin when given together with fluorouracil and leucovorin calcium in pediatric patients with recurrent or refractory solid tumors, including tumors of the CNS.
SECONDARY OBJECTIVES:
- Determine the pharmacokinetic properties of oxaliplatin in this pediatric patient population.
II. Correlate alterations in accumulation of fludeoxyglucose F 18 with tumor response in those patients who can readily undergo a positron emission tomography (PET) or PET/CT scan.
III. Assess the safety profile of this regimen in these patients. IV. Evaluate any preliminary evidence of anti-tumor activity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of oxaliplatin. Patients are stratified according to solid tumor type (non-CNS vs CNS).
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2. Courses repeat every 14 days 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
- Conditions
- Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Embryonal Tumor, Childhood Central Nervous System Germ Cell Tumor, Childhood Central Nervous System Germinoma, Childhood Central Nervous System Mixed Germ Cell Tumor, Childhood Central Nervous System Teratoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
fluorouracilDrug
Also called 5-fluorouracil, 5-Fluracil, 5-FU
Given IV
Also called CF, CFR, LV
Given IV
Also called pharmacological studies
Correlative studies
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo PET scan
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Treatment (oxaliplatin, leucovorin calcium, fluorouracil) | Experimental | Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: oxaliplatin; Drug: fluorouracil; Drug: leucovorin calcium; Other: pharmacological study; Procedure: positron emission tomography; Procedure: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD based on the incidence of DLT as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 3.0
Measured: 14 days
DLT defined as any grade 3 or greater non-hematologic toxicity attributed to the combination of drugs in this regimen, despite maximal supportive care as assessed by NCI CTCAE v. 3
Measured: 14 days
Secondary outcomes (2)
Safety profile as assessed by NCI CTCAE v. 3.0
Any incidence of adverse events will be recorded and classified according to body region and severity.
Measured: 14 days
Tumor response based on PET or PET/CT scan
Wilcoxon rank sum statistic will be used to assess whether tumor response is associated with the change in the PET SUV value.
Measured: From baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startSep 2005
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Central Nervous System ChoriocarcinomaStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lia Gore, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281944
- Sponsor's protocol ID
- NCI-2009-01051
- Other IDs
- 04-0336, MSKCC-040336, CDR0000454709, NCI-6952, POETIC-COMIRB-040336
- Status last verified
- May 2013
- First submitted
- 24 Jan 2006
- Last updated
- 3 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Phase Ib Study of Oxaliplatin (NSC #266046) in Combination With Fluorouracil and Leucovorin in Pediatric Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00281944
- Acronym / sponsor ID
- NCI-2009-01051
- Conditions
- Childhood Central Nervous System Choriocarcinoma, Childhood Central Nervous System Embryonal Tumor, Childhood Central Nervous System Germ Cell Tumor, Childhood Central Nervous System Germinoma, Childhood Central Nervous System Mixed Germ Cell Tumor, Childhood Central Nervous System Teratoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2005
- Primary completion
- May 2009 (actual)
- First posted
- 25 Jan 2006 (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.
This phase I trial is studying the side effects and best dose of oxaliplatin when given together with leucovorin and fluorouracil in treating young patients with advanced solid tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of oxaliplatin when given together with fluorouracil and leucovorin calcium in pediatric patients with recurrent or refractory solid tumors, including tumors of the CNS.
SECONDARY OBJECTIVES:
- Determine the pharmacokinetic properties of oxaliplatin in this pediatric patient population.
II. Correlate alterations in accumulation of fludeoxyglucose F 18 with tumor response in those patients who can readily undergo a positron emission tomography (PET) or PET/CT scan.
III. Assess the safety profile of this regimen in these patients. IV. Evaluate any preliminary evidence of anti-tumor activity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of oxaliplatin. Patients are stratified according to solid tumor type (non-CNS vs CNS).
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2. Courses repeat every 14 days 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (oxaliplatin, leucovorin calcium, fluorouracil) | Experimental | Drug: oxaliplatin, Drug: fluorouracil, Drug: leucovorin calcium, Other: pharmacological study, Procedure: positron emission tomography, Procedure: computed tomographyPatients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (45 listed)
- Histologically diagnosed malignant solid tumor, including tumors of the CNS, that has progressed despite standard therapy or for which no effective standard therapy is known
- Measurable or nonmeasurable disease
- No pleural effusion or ascites causing respiratory compromise (≥ grade 2 dyspnea)
- ECOG performance status (PS) 0-2 for patients ≥ 16 years of age
- Karnofsky PS ≥ 40% for patients > 10 years of age
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV | Drug | Treatment (oxaliplatin, leucovorin calcium, fluorouracil) |
| fluorouracilAlso: 5-fluorouracil, 5-Fluracil, 5-FUGiven IV | Drug | Treatment (oxaliplatin, leucovorin calcium, fluorouracil) |
| leucovorin calciumAlso: CF, CFR, LVGiven IV | Drug | Treatment (oxaliplatin, leucovorin calcium, fluorouracil) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (oxaliplatin, leucovorin calcium, fluorouracil) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo PET scan | Procedure or surgery | Treatment (oxaliplatin, leucovorin calcium, fluorouracil) |
| computed tomographyAlso: tomography, computedUndergo PET/CT scan | Procedure or surgery | Treatment (oxaliplatin, leucovorin calcium, fluorouracil) |
Primary outcome
MTD based on the incidence of DLT as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 3.0
Time frame: 14 days
DLT defined as any grade 3 or greater non-hematologic toxicity attributed to the combination of drugs in this regimen, despite maximal supportive care as assessed by NCI CTCAE v. 3
Time frame: 14 days
2 secondary outcomes
Safety profile as assessed by NCI CTCAE v. 3.0
Time frame: 14 days
Tumor response based on PET or PET/CT scan
Time frame: From baseline to 6 weeks
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 3 May 2013.
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.
Lia Gore principal investigator
Memorial Sloan Kettering Cancer Center
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, fluorouracil and leucovorin calcium in people with Childhood Central Nervous System Choriocarcinoma and Childhood Central Nervous System Embryonal Tumor, run by National Cancer Institute (NCI) 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?
The sponsor lists 45 inclusion and 0 exclusion criteria. 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 3 May 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 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.
What does the primary outcome measure?
MTD based on the incidence of DLT as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 3.0 (time frame: 14 days). 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 3 May 2013; AzTrials last refreshed its copy on 1 Nov 2026.