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Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors; Neurofibromatosis Type 1

Intervention: carboplatin (Drug); vinblastine sulfate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Regina Jakacki, MD, Study Chair, Affiliation: Children's Hospital of Pittsburgh of UPMC
Eric Bouffet, MD, MRCP, Study Chair, Affiliation: The Hospital for Sick Children

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. 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.

Clinical Details

Official title: A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Acute and dose-limiting toxicities

Other toxicities

Secondary outcome:

Radiographic response

Changes in diffusion/perfusion imaging

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.

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama 35294, United States

Children's Hospital of Orange County, Orange, California 92868, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan 48109-0286, United States

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri 63110, United States

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

Oregon Health and Science University Cancer Institute, Portland, Oregon 97239-3098, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-9786, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States

Baylor University Medical Center - Houston, Houston, Texas 77030-2399, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2006
Last updated: February 11, 2014

Page last updated: August 23, 2015

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