Brain TumorNCT00077207

Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma

A study testing carboplatin, temozolomide and vincristine sulfate in people with Brain Tumor and Central Nervous System Tumor, run by Children's Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. Read more about this study

Who is it for?: Ages Up to 10 years
Conditions the study is for: Brain Tumor, Central Nervous System Tumor
What is being tested?: carboplatin, temozolomide and vincristine sulfate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: Jul 2004to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 years
All sexes
No healthy volunteers
Child

DISEASE CHARACTERISTICS:

Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following:
WHO grade I or II astrocytoma
Grade I or II oligodendrogliomas
Mixed oligodendrogliomas
Gangliogliomas
Measurable disease
Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be removed for anatomical reasons are allowed
Optic pathway tumors allowed provided there is evidence of progressive disease by MRI and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary dysfunction, or diencephalic syndrome
Dorsally exophytic brainstem gliomas that were previously resected more than 50% are allowed provided the residual tumor shows progression (with or without symptoms)
No diffuse brain stem tumors
No type 1 neurofibromatosis

PATIENT CHARACTERISTICS:

Age

10 and under

Performance status

ECOG 0-2
Lansky 50-100%

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 8.0 gm/dL
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT < 2.5 times ULN

Renal

Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10)

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immunomodulating agents

Chemotherapy

No other concurrent anticancer chemotherapy

Endocrine therapy

Prior corticosteroids allowed
No concurrent corticosteroids except for the treatment of increased intracranial pressure

Radiotherapy

Not specified

Surgery

See Disease Characteristics
Prior surgery allowed

Other

No other prior therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Childrens Oncology Group
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas

PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.

Read the detailed description

OBJECTIVES:

Primary

Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptomatic low-grade gliomas.

Secondary

Determine response rate in patients treated with this regimen.
Determine 3-year progression-free survival and overall survival of patients treated with this regimen.
Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen.

OUTLINE: This is a pilot study.

Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and 22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy.
Maintenance therapy: Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.

Conditions: Brain Tumor, Central Nervous System Tumor
Being tested: carboplatin, temozolomide, vincristine sulfate
Keywords: untreated childhood cerebellar astrocytoma, untreated childhood visual pathway and hypothalamic glioma, childhood spinal cord neoplasm, childhood oligodendroglioma, childhood low-grade cerebral astrocytoma
Medical subject headings: Brain Neoplasms, Central Nervous System Neoplasms, Spinal Cord Neoplasms, Oligodendroglioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

carboplatinDrug
Also called Paraplatin, NSC #241240
Given IV
temozolomideDrug
Also called Temodar, NSC# 362856
Given orally
vincristine sulfateDrug
Also called Oncovin, VCR, LCR, NSC #67574
Given IV

Study groups in NCT00077207
Study group	Role	What they receive
Treatment (carboplatin, vincristine sulfate, temozolomide)	Experimental	Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. Receives: Drug: carboplatin; Drug: temozolomide; Drug: vincristine sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

Short Term Feasibility Success
Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.
Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure.
Measured: 24 weeks
Long Term Feasibility Success
Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.
If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success.
Measured: 60 weeks

Secondary outcomes (5)

Number of Participants Who Experienced Toxic Death
Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.
Measured: Up to 6 years after the start of protocol therapy
Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.
Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.
Measured: Up to 18 months of protocol therapy
Percent Probability of Progression-free Survival (PFS)
Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.
Measured: 3 years
Percentage Probability of Event-free Survival (EFS)
Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.
Measured: Six years
Total Number of Patients Experiencing a Response
Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.
Measured: Up to 18 months of protocol therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Dec 2013

First posted11 Feb 2004 (estimated)
Study startJul 2004
Primary completionMar 2010
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Brain 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00077207
Sponsor's protocol ID: ACNS0223
Other IDs: CDR0000350005, COG-ACNS0223, NCI-2012-02572
Status last verified: Apr 2018
First submitted: 10 Feb 2004
Last updated: 16 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chintagumpala M, Eckel SP, Krailo M, Morris M, Adesina A, Packer R, Lau C, Gajjar A. A pilot study using carboplatin, vincristine, and temozolomide in children with progressive/symptomatic low-grade glioma: a Children's Oncology Group studydagger. Neuro Oncol. 2015 Aug;17(8):1132-8. doi: 10.1093/neuonc/nov057. Epub 2015 Apr 7.
PubMed 25854526

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas
ClinicalTrials.gov ID: NCT00077207
Acronym / sponsor ID: ACNS0223
Conditions: Brain Tumor, Central Nervous System Tumor
Keywords: untreated childhood cerebellar astrocytoma, untreated childhood visual pathway and hypothalamic glioma, childhood spinal cord neoplasm, childhood oligodendroglioma, childhood low-grade cerebral astrocytoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Children's Oncology GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Jul 2004
Primary completion: Mar 2010 (actual)
Study completion: Dec 2013 (actual)
First posted: 11 Feb 2004 (estimated)
Results: Posted 2 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.

Detailed description

OBJECTIVES:

Primary

Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptomatic low-grade gliomas.

Secondary

Determine response rate in patients treated with this regimen.
Determine 3-year progression-free survival and overall survival of patients treated with this regimen.
Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen.

OUTLINE: This is a pilot study.

Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and 22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy.
Maintenance therapy: Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (carboplatin, vincristine sulfate, temozolomide)	Experimental	Drug: carboplatin, Drug: temozolomide, Drug: vincristine sulfateInduction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Who may qualify

Ages: Up to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

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
carboplatinAlso: Paraplatin, NSC #241240Given IV	Drug	Treatment (carboplatin, vincristine sulfate, temozolomide)
temozolomideAlso: Temodar, NSC# 362856Given orally	Drug	Treatment (carboplatin, vincristine sulfate, temozolomide)
vincristine sulfateAlso: Oncovin, VCR, LCR, NSC #67574Given IV	Drug	Treatment (carboplatin, vincristine sulfate, temozolomide)

Primary outcome

Short Term Feasibility Success
Time frame: 24 weeks
Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure.
Long Term Feasibility Success
Time frame: 60 weeks
Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success.

5 secondary outcomes

Number of Participants Who Experienced Toxic Death
Time frame: Up to 6 years after the start of protocol therapy
Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.
Time frame: Up to 18 months of protocol therapy
Percent Probability of Progression-free Survival (PFS)
Time frame: 3 years
Percentage Probability of Event-free Survival (EFS)
Time frame: Six years
Total Number of Patients Experiencing a Response
Time frame: Up to 18 months of protocol therapy

Results and safety

Results posted to the registry on 2 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)	66	36

Primary outcome: Short Term Feasibility Success

Time frame: 24 weeks. Number. Unit: participants

Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n = 52
Value	25

Population analysed: Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.

Primary outcome: Long Term Feasibility Success

Time frame: 60 weeks. Number. Unit: participants

Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n = 52
Value	41

Population analysed: Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)	6 of 64 (9.4%)	50 of 64 (78.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25854526Chintagumpala M, Eckel SP, Krailo M, Morris M, Adesina A, Packer R, Lau C, Gajjar A. A pilot study using carboplatin, vincristine, and temozolomide in children with progressive/symptomatic low-grade glioma: a Children's Oncology Group studydagger. Neuro Oncol. 2015 Aug;17(8):1132-8. doi: 10.1093/neuonc/nov057. Epub 2015 Apr 7.

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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.

Murali M. Chintagumpala, MD study chair

Texas Children's Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing carboplatin, temozolomide and vincristine sulfate in people with Brain Tumor and Central Nervous System 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?

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 16 May 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Short Term Feasibility Success (time frame: 24 weeks). 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?

On the ClinicalTrials.gov record for NCT00077207, which also lists 1 linked publication.

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 16 May 2018.