search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carboplatin
cereport
radiation therapy
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring untreated childhood brain stem glioma

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • Lucile Packard Children's Hospital at Stanford
  • UCSF Comprehensive Cancer Center
  • Children's National Medical Center
  • Indiana University Cancer Center
  • MBCCOP - LSU Health Sciences Center
  • Dana-Farber Cancer Institute
  • Mayo Clinic Cancer Center
  • University of Mississippi Medical Center
  • Albert Einstein Clinical Cancer Center
  • Herbert Irving Comprehensive Cancer Center
  • State University of New York - Upstate Medical University
  • Children's Hospital Medical Center - Cincinnati
  • Doernbecher Children's Hospital
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • University of Texas - MD Anderson Cancer Center
  • Baylor College of Medicine
  • Children's Hospital and Regional Medical Center - Seattle

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days

Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days

Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days

Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival
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

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
February 19, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00005602
Brief Title
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Official Title
Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
untreated childhood brain stem glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days
Arm Type
Experimental
Arm Title
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days
Arm Type
Experimental
Arm Title
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days
Arm Type
Experimental
Arm Title
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin, CBDCA, NSC #241240
Intervention Type
Drug
Intervention Name(s)
cereport
Other Intervention Name(s)
labradimil, IND #60315
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger J. Packer, MD
Organizational Affiliation
Children's National Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Lucile Packard Children's Hospital at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Children's Hospital Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs