Childhood Central Nervous System Germ Cell TumorPhase 2NCT00004078
Irinotecan in Treating Children With Refractory Solid Tumors
A Phase 2 study testing irinotecan hydrochloride in people with Childhood Central Nervous System Germ Cell Tumor and Childhood Choroid Plexus Tumor, run by Children's Oncology Group at 1 site in United States.
Trial summary
This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma
- What is being tested?
- irinotecan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Oct 2007
- Phase
- Phase 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy
- Solid tumors:
- Neuroblastoma
- Ewing's Sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Osteosarcoma
- Rhabdomyosarcoma
Show all 51Show fewer
- Other extracranial solid tumors
- CNS tumors:
- Medulloblastoma/PNET
- Ependymoma
- Brain stem glioma
- Other CNS tumor
- Intrinsic brain stem tumor (biopsy required only if previously treated with radiosurgery)
- Classic optic glioma (histologic requirement waived)
- Measurable disease by imaging studies
- No lesions assessable only by radionuclide scan
- Previously irradiated lesions used to evaluate tumor response must show evidence of an interim increase in size
- Performance status - Karnofsky 50-100% if more than 10 years old
- Performance status - Lansky 50-100% if 10 years or younger
- At least 8 weeks
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8 mg/dL
- Inadequate peripheral blood counts due to bone marrow infiltration allowed
- Bilirubin no greater than 1.5 mg/dL
- SGPT less than 5 times normal
- Creatinine normal
- Glomerular filtration rate at least 70 mL/min
- No severe uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- At least 3 weeks since prior immunotherapy and recovered
- No concurrent biologic therapy
- At least 3 weeks since prior chemotherapy (8 weeks since prior nitrosoureas) and recovered
- No more than 2 prior chemotherapy regimens
- No other concurrent chemotherapy
- Prior topotecan allowed
- No prior irinotecan
- Concurrent dexamethasone for brain tumor patients allowed if on a stable or decreasing dose for at least 2 weeks prior to study
- At least 3 weeks since prior endocrine therapy
- No other concurrent endocrine therapy
- See Disease Characteristics
- At least 8 weeks since prior extended radiotherapy (including evaluable lesions) and recovered
- No prior total body radiotherapy
- No concurrent radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior investigational agents
- No other concurrent investigational agents
- No concurrent anticonvulsants
- No concurrent medications that would interfere with the P-450 enzyme system function (e.g., erythromycin, cimetidine, fluconazole)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Arcadia, California, 91006-3776
About this study
Official title: Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of irinotecan in children with refractory CNS or solid tumors.
II. Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this patient population.
III. Determine patient UGT1A1 genotype and correlate genotype with toxicity and pharmacokinetic parameters of this regimen in these patients.
OUTLINE: Patients are stratified according to type of solid tumor (Ewings/PNET vs neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas and brain tumors) or brain tumor (medulloblastoma/PNET vs brain stem glioma vs ependymoma vs other CNS tumors).
Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.
- Conditions
- Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma
- Being tested
- irinotecan hydrochloride
- Medical subject headings
- Choroid Plexus Neoplasms, Oligodendroglioma, Astrocytoma, Familial ependymoma, Medulloblastoma, Optic Nerve Glioma, Neuroectodermal Tumors, Primitive, Peripheral, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Campto, Camptosar, CPT-11, irinotecan
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (irinotecan hydrochloride) | Experimental | Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study. Receives: Drug: irinotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response (PR or CR), recorded according to standard solid tumor response criteria
Measured: Up to 8 years
Secondary outcomes (2)
Toxicity, graded using the NCI CTCAE version 2.0
Measured: Up to 8 years
Pharmacokinetics of irinotecan hydrochloride
Measured: Day 1 of course 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startOct 1999
- Primary completionOct 2007
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 Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Bomgaars, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004078
- Sponsor's protocol ID
- P9761
- Other IDs
- NCI-2012-02310, CDR0000067288, POG-9761, CCG-P9761, COG-P9761, U10CA098543
- Status last verified
- Jun 2013
- First submitted
- 10 Dec 1999
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00004078
- Acronym / sponsor ID
- P9761
- Conditions
- Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Oct 2007 (actual)
- First posted
- 28 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.
This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES:
- Determine the efficacy of irinotecan in children with refractory CNS or solid tumors.
II. Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this patient population.
III. Determine patient UGT1A1 genotype and correlate genotype with toxicity and pharmacokinetic parameters of this regimen in these patients.
OUTLINE: Patients are stratified according to type of solid tumor (Ewings/PNET vs neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas and brain tumors) or brain tumor (medulloblastoma/PNET vs brain stem glioma vs ependymoma vs other CNS tumors).
Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (irinotecan hydrochloride) | Experimental | Drug: irinotecan hydrochloridePatients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (51 listed)
- Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy
- Measurable disease by imaging studies
- Previously irradiated lesions used to evaluate tumor response must show evidence of an interim increase in size
- Performance status - Karnofsky 50-100% if more than 10 years old
- Performance status - Lansky 50-100% if 10 years or younger
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 |
|---|---|---|
| irinotecan hydrochlorideAlso: Campto, Camptosar, CPT-11, irinotecanGiven IV | Drug | Treatment (irinotecan hydrochloride) |
Primary outcome
Objective response (PR or CR), recorded according to standard solid tumor response criteria
Time frame: Up to 8 years
2 secondary outcomes
Toxicity, graded using the NCI CTCAE version 2.0
Time frame: Up to 8 years
Pharmacokinetics of irinotecan hydrochloride
Time frame: Day 1 of course 1
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 14 Jun 2013.
Related trials for Childhood Central Nervous System Germ Cell Tumor
RecruitingPhase 2
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
Diffuse Intrinsic Pontine Glioma, DIPG
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
Active, not recruitingPhase 1
Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma
RecruitingPhase 1
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS
RecruitingPhase 1
GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults
Medulloblastoma, Central Nervous System Embryonal Tumor
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.
Lisa Bomgaars principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan hydrochloride in people with Childhood Central Nervous System Germ Cell Tumor and Childhood Choroid Plexus Tumor, run by Children's Oncology Group 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 51 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 14 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 phase mean?
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?
Objective response (PR or CR), recorded according to standard solid tumor response criteria (time frame: Up to 8 years). 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 14 Jun 2013.