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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00352495
• Date of registration: 13/07/2006
• Prospective Registration: No
• Primary sponsor: Children's Oncology Group
• Public title: Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
• Scientific title: A Phase I Study of Vinblastine in Combination With Carboplatin for Children With Newly Diagnosed and Recurrent Low-Grade Gliomas
• Date of first enrolment: June 2006
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00352495
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada, United States

Contacts

• Name: Regina Jakacki, MD
• Affiliation: Children's Hospital of Pittsburgh of UPMC

• Name: Eric Bouffet, MD, MRCP
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Neurofibromatosis Type 1

Brain and Central Nervous System Tumors

Intervention(s)

Drug: carboplatin

Drug: vinblastine sulfate

Primary Outcome(s)

Acute and dose-limiting toxicities [Time Frame: length of study]

Maximum tolerated dose and recommended phase II dose of vinblastine in combination with carboplatin [Time Frame: length of study]

Other toxicities [Time Frame: length of study]

Secondary Outcome(s)

Changes in diffusion/perfusion imaging [Time Frame: length of study]

Radiographic response [Time Frame: length of study]

Secondary ID(s)

ADVL0515

COG-ADVL0515

CDR0000483184

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)