Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Temporarily closed 3 to 21 NCI COG-ADVL0012 CCG-ADVL0012, ALK-01-042, CCG-09802, NCT00005602, ADVL00012

Objectives

1. Determine the maximum tolerated duration of lobradimil plus carboplatin with radiotherapy in patients with newly diagnosed brain stem gliomas.
2. Determine the toxic effects of this treatment regimen in these patients.
3. Assess the response to radiotherapy in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Newly diagnosed diffuse, intrinsic brain stem gliomas



• Measurable disease



• No disseminated disease at sites other than brain stem



• No neurofibromatosis



• Treatment must begin within 31 days of diagnosis
  • Date of diagnosis will be considered date of surgery in patients undergoing surgical biopsy

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent growth factors during therapy with carboplatin

Chemotherapy

• Not specified

Endocrine therapy

• Prior corticosteroids for brain stem glioma are allowed

Radiotherapy

• Not specified

Surgery

• Prior surgery for brain stem glioma is allowed

Other

• At least 24 hours since any of the following medications:
  • Vasodilating compounds
  • Angiotensin-converting enzyme inhibitors
  • Calcium channel blockers
  • Beta blockers
• No other prior therapy for brain stem glioma

Patient Characteristics:

Age:

• 3 to 21

Performance status:

• Karnofsky 50-100% (over 10 years of age)
• Lansky 50-100% (10 years of age and under)

Life expectancy:

• At least 2 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGPT no greater than 2.5 times ULN (4.0 times ULN with antiepileptic or steroid medications)

Renal:

• Creatinine less than ULN for age

  OR

• Creatinine clearance or glomerular filtration rate greater than 80 mL/min

Other:

• No history of severe allergic reaction to any platinum-containing compound
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 15-24 patients will be accrued for this study within 36 months.

Outline

Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV over 10 minutes concurrently with radiotherapy.

The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until unacceptable toxicity occurs in 2 of 6 patients.

Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Roger Packer, MD, Protocol chair		Ph: 202-884-2120

Registry Information
Official Title		Phase I Study of Concurrent Cereport and Carboplatin with Radiation Therapy for Children with Newly-Diagnosed Brain Stem Gliomas
Trial Start Date		2001-02-02
Registered in ClinicalTrials.gov		NCT00005602
Date Submitted to PDQ		2000-03-01
Information Last Verified		2003-09-08
NCI Grant/Contract Number		U01-CA57746