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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005602
• Other study ID #: ADVL0012
• Secondary ID: COG-ADVL0012CCG-
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2000
• Last updated: February 19, 2014
• Start date: February 2001
• Est. completion date: September 2005

Study information

• Verified date: February 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• carboplatin

• cereport

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	Children's Hospital Medical Center - Cincinnati	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Doernbecher Children's Hospital	Portland	Oregon
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Yes