Brain and Central Nervous System TumorsPhase 1NCT00352495
Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
A Phase 1 study testing carboplatin and vinblastine sulfate in people with Brain and Central Nervous System Tumors and Neurofibromatosis Type 1, run by Children's Oncology Group at 21 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, 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 more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Neurofibromatosis Type 1
- What is being tested?
- carboplatin and vinblastine sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jun 2006to Mar 2012
- 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* low-grade glioma, including 1 of the following subtypes:
- Astrocytoma variants
- Fibrillary, protoplasmic, or mixed
- Pilocytic astrocytoma, including pilomyxoid variants
- Pleomorphic xanthoastrocytoma
- Infantile desmoplastic astrocytoma
- Ganglioglioma
- Oligodendroglial tumors
- Mixed glioma, including oligoastrocytoma NOTE: *Biopsy not required for patients who have visual pathway tumors involving the optic nerves and/or optic radiations (i.e., not isolated to the hypothalamus/chiasm)
- Biopsy proven focal low-grade gliomas of the brainstem with measurable disease allowed
- No diffuse, intrinsic brainstem tumors
- Residual tumor visible on MRI
- Patients without NF-1 must meet the following criteria:
- Progressive disease after surgery/biopsy based on clear radiographic or clinical evidence of progression OR gross residual tumor (> 1.5 cm²) after surgery/biopsy that is felt to be a high risk to the patient for neurologic and/or visual impairment if the tumor progresses
- Visual pathway tumors that are not isolated to the hypothalamus/chiasm and are not biopsied must be a high risk to the patient for neurologic and/or visual impairment
- Patients with NF-1 must have evidence of radiographic progression on MRI and/or clinical worsening (e.g., worsening of ophthalmologic exam for visual pathway tumors)
- Meets 1 of the following criteria:
- Newly diagnosed disease
- Recurrent disease
- No ventriculoperitoneal shunt-related ascites
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% (for patients > 10 years of age) OR Lansky PS 50-100% (for patients ≤ 10 years of age)
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³ (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age, as follows:
- No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
- No greater than 1.0 mg/dL (for patients 6-10 years of age)
- No greater than 1.2 mg/dL (for patients 11-15 years of age)
- No greater than 1.5 mg/dL (for patients > 15 years of age)
- Bilirubin ≤ 1.5 times upper limit of normal
- ALT ≤ 110 U/L
- Albumin ≥ 2 g/dL
- No history of allergy to carboplatin
- No hyponatremia requiring treatment
- No uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior therapy except for corticosteroids and surgery (for patients with newly diagnosed disease)
- Prior chemotherapy and/or radiotherapy in addition to surgery and corticosteroids allowed (for patients with recurrent disease)
- Prior carboplatin and/or vinblastine allowed if there was no evidence of progressive disease while on therapy and there were no dose reductions due to toxicity (for patients with recurrent disease)
- At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered (for patients with recurrent disease)
- At least 7 days since prior hematopoietic growth factors (for patients with recurrent disease)
- At least 7 days since prior biological agents (for patients with recurrent disease)
- At least 9 months since prior external beam radiotherapy or gamma knife therapy that included all target lesions (i.e., there is no restriction if a new lesion arises outside the radiation field or a nonirradiated lesion progresses) and recovered (for patients with recurrent disease)
- No other concurrent investigational drugs
- No other concurrent anticancer agents
- No other concurrent chemotherapy, radiotherapy, immunotherapy, or biological therapy
- No concurrent corticosteroids for antiemesis
- Concurrent steroids allowed for tumor edema/increased intracranial pressure provided dose of dexamethasone is stable or decreasing for the past 7 days
- Concurrent physiologic or stress doses of steroids allowed for endocrine deficiencies
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0286
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, 35294
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Baylor University Medical Center - Houston
Houston, Texas, 77030-2399
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-9786
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University Cancer Institute
Portland, Oregon, 97239-3098
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Canada2 sites
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas
RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, 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.
PURPOSE: This phase I trial is studying the side effects and best dose of vinblastine when given together with carboplatin in treating young patients with newly diagnosed or recurrent low-grade glioma.
Read the detailed description
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose and recommended phase II dose of vinblastine when given in combination with carboplatin in pediatric patients with newly diagnosed or recurrent low-grade gliomas.
- Define and describe the acute and dose-limiting toxicities of this regimen.
- Describe the toxicities associated with repeated courses of the combination chemotherapy regimen and the number of treatment modifications required over the course of treatment.
Secondary
- Describe the radiographic responses in patients treated with this regimen.
- Describe changes in diffusion/perfusion imaging during study therapy.
OUTLINE: This is a multicenter, dose-escalation study of vinblastine. Patients are stratified according to amount of prior therapy (heavily pretreated vs less heavily pretreated).
Patients receive carboplatin IV over 30 minutes on day 1 and vinblastine IV on days 1, 8, 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vinblastine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
- Being tested
- carboplatin, vinblastine sulfate
- Keywords
- childhood low-grade cerebral astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, childhood oligodendroglioma, neurofibromatosis type 1, recurrent childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway and hypothalamic glioma
- Medical subject headings
- Central Nervous System Neoplasms, Neurofibromatosis 1, Astrocytoma, Oligodendroglioma, Optic Nerve Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
vinblastine sulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| Vinblastine sulfate and carboplatin | Experimental | The MTD of vinblastine in combination with a monthly dose of carboplatin will be determined during the first cycle of therapy. Each 4-week cycle will consist of carboplatin once every 4 weeks on day 1. Vinblastine will be given once a week for 3 weeks followed by a one week break. Doses of carboplatin and vinblastine sulfate will be assigned at study enrollment. Patients may receive eleven additional four week cycles, barring tumor progression or unacceptable toxicity. The total duration of therapy will be approximately 48 weeks. Receives: Drug: carboplatin; Drug: vinblastine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin
Measured: length of study
Acute and dose-limiting toxicities
Measured: length of study
Other toxicities
Measured: length of study
Secondary outcomes (2)
Radiographic response
Measured: length of study
Changes in diffusion/perfusion imaging
Measured: length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Regina Jakacki, MD, Study chair, University of PittsburghEric Bouffet, MD, MRCP, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352495
- Sponsor's protocol ID
- ADVL0515
- Other IDs
- COG-ADVL0515, CDR0000483184
- Status last verified
- Feb 2014
- First submitted
- 13 Jul 2006
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jakacki RI, Bouffet E, Adamson PC, Pollack IF, Ingle AM, Voss SD, Blaney SM. A phase 1 study of vinblastine in combination with carboplatin for children with low-grade gliomas: a Children's Oncology Group phase 1 consortium study. Neuro Oncol. 2011 Aug;13(8):910-5. doi: 10.1093/neuonc/nor090. Epub 2011 Jul 15.
PubMed 21764821
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00352495
- Acronym / sponsor ID
- ADVL0515
- Keywords
- childhood low-grade cerebral astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, childhood oligodendroglioma, neurofibromatosis type 1, recurrent childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway and hypothalamic glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Jul 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.
RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, 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.
PURPOSE: This phase I trial is studying the side effects and best dose of vinblastine when given together with carboplatin in treating young patients with newly diagnosed or recurrent low-grade glioma.
Detailed description
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose and recommended phase II dose of vinblastine when given in combination with carboplatin in pediatric patients with newly diagnosed or recurrent low-grade gliomas.
- Define and describe the acute and dose-limiting toxicities of this regimen.
- Describe the toxicities associated with repeated courses of the combination chemotherapy regimen and the number of treatment modifications required over the course of treatment.
Secondary
- Describe the radiographic responses in patients treated with this regimen.
- Describe changes in diffusion/perfusion imaging during study therapy.
OUTLINE: This is a multicenter, dose-escalation study of vinblastine. Patients are stratified according to amount of prior therapy (heavily pretreated vs less heavily pretreated).
Patients receive carboplatin IV over 30 minutes on day 1 and vinblastine IV on days 1, 8, 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vinblastine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vinblastine sulfate and carboplatin | Experimental | Drug: carboplatin, Drug: vinblastine sulfateThe MTD of vinblastine in combination with a monthly dose of carboplatin will be determined during the first cycle of therapy. Each 4-week cycle will consist of carboplatin once every 4 weeks on day 1. Vinblastine will be given once a week for 3 weeks followed by a one week break. Doses of carboplatin and vinblastine sulfate will be assigned at study enrollment. Patients may receive eleven additional four week cycles, barring tumor progression or unacceptable toxicity. The total duration of therapy will be approximately 48 weeks. |
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 |
|---|---|---|
| carboplatin | Drug | Vinblastine sulfate and carboplatin |
| vinblastine sulfate | Drug | Vinblastine sulfate and carboplatin |
Primary outcome
Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin
Time frame: length of study
Acute and dose-limiting toxicities
Time frame: length of study
Other toxicities
Time frame: length of study
2 secondary outcomes
Radiographic response
Time frame: length of study
Changes in diffusion/perfusion imaging
Time frame: length of study
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 13 Feb 2014.
- Results publication: PubMed 21764821Jakacki RI, Bouffet E, Adamson PC, Pollack IF, Ingle AM, Voss SD, Blaney SM. A phase 1 study of vinblastine in combination with carboplatin for children with low-grade gliomas: a Children's Oncology Group phase 1 consortium study. Neuro Oncol. 2011 Aug;13(8):910-5. doi: 10.1093/neuonc/nor090. Epub 2011 Jul 15.
Related trials for Brain and Central Nervous System Tumors
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
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.
Regina Jakacki, MD study chair
University of Pittsburgh
Eric Bouffet, MD, MRCP study chair
The Hospital for Sick Children
21 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 carboplatin and vinblastine sulfate in people with Brain and Central Nervous System Tumors and Neurofibromatosis Type 1, run by Children's Oncology Group at 21 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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.
What does the primary outcome measure?
Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin (time frame: length of study). The study lists 3 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 NCT00352495, 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 13 Feb 2014.