NCT00005602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_1

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2000

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

3.9 years

First QC Date

May 2, 2000

Last Update Submit

February 19, 2014

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood brain stem glioma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

EXPERIMENTAL
Drug: carboplatinDrug: cereportRadiation: radiation therapy

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

EXPERIMENTAL
Drug: carboplatinDrug: cereportRadiation: radiation therapy

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

EXPERIMENTAL
Drug: carboplatinDrug: cereportRadiation: radiation therapy

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

EXPERIMENTAL
Drug: carboplatinDrug: cereportRadiation: radiation therapy

Interventions

carboplatinDRUG
Also known as: Paraplatin, CBDCA, NSC #241240
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days
cereportDRUG
Also known as: labradimil, IND #60315
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days
radiation therapyRADIATION
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 DaysRadiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days

Eligibility Criteria

Age3 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (19)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0128, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Doernbecher Children's Hospital

Portland, Oregon, 97201-3098, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

CarboplatinRMP 7Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTherapeutics

Study Officials

  • Roger J. Packer, MD

    Children's National Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

February 1, 2001

Primary Completion

January 1, 2005

Study Completion

September 1, 2005

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

US(19)