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Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas


Phase 1
3 Years
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With 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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Roger J. Packer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067715

NCT ID:

NCT00005602

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood brain stem glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304