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Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
This study has been suspended.
Study NCT00005602   Information provided by National Cancer Institute (NCI)
First Received: May 2, 2000   Last Updated: February 6, 2009   History of Changes

May 2, 2000
February 6, 2009
February 2001
 
 
 
Complete list of historical versions of study NCT00005602 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.

OBJECTIVES:

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

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.

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

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: carboplatin
  • Drug: lobradimil
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
 
 
 

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

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/mm^3
  • Platelet count at least 100,000/mm^3
  • 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

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
Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005602
 
CDR0000067715, COG-ADVL0012, CCG-ADVL0012, ALK-01-042, CCG-09802
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Roger J. Packer, MD Children's Research Institute
National Cancer Institute (NCI)
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP