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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.

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 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
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

Other trials in United States

Canada2 sites
  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

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.

Study groups in NCT00352495
Study groupRoleWhat they receive
Vinblastine sulfate and carboplatinExperimentalThe 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.

  1. Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin

    Measured: length of study

  2. Acute and dose-limiting toxicities

    Measured: length of study

  3. Other toxicities

    Measured: length of study

Secondary outcomes (2)
  1. Radiographic response

    Measured: length of study

  2. 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.

  1. First posted14 Jul 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionSep 2011
  4. Study completionMar 2012

Resources

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)
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

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.

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