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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00005602
First received: May 2, 2000
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carboplatin
Drug: cereport
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Progression Free Survival [ Designated as safety issue: Yes ]
    A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years


Enrollment: 13
Study Start Date: February 2001
Study Completion Date: September 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days Drug: carboplatin
Other Names:
  • Paraplatin
  • CBDCA
  • NSC #241240
Drug: cereport
Other Names:
  • Cereport
  • labradimil
  • IND #60315
Radiation: radiation therapy
Experimental: Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days Drug: carboplatin
Other Names:
  • Paraplatin
  • CBDCA
  • NSC #241240
Drug: cereport
Other Names:
  • Cereport
  • labradimil
  • IND #60315
Radiation: radiation therapy
Experimental: Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days Drug: carboplatin
Other Names:
  • Paraplatin
  • CBDCA
  • NSC #241240
Drug: cereport
Other Names:
  • Cereport
  • labradimil
  • IND #60315
Radiation: radiation therapy
Experimental: Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days Drug: carboplatin
Other Names:
  • Paraplatin
  • CBDCA
  • NSC #241240
Drug: cereport
Other Names:
  • Cereport
  • labradimil
  • IND #60315
Radiation: radiation therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005602

Locations
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
United States, Oregon
Doernbecher Children's Hospital
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Roger J. Packer, MD Children's Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00005602     History of Changes
Other Study ID Numbers: ADVL0012, COG-ADVL0012, CCG-ADVL0012, ALK-01-042, CCG-09802, CDR0000067715
Study First Received: May 2, 2000
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
untreated childhood brain stem glioma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014