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High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas

Study Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Isotretinoin may be effective in preventing recurrence of glioma. It is not yet known which regimen of chemotherapy plus autologous stem cell transplantation with or without isotretinoin is more effective in treating recurrent high-grade glioma. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation to see how well it works compared to high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation and isotretinoin in treating young patients with recurrent high-grade glioma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 20 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed diagnosis of 1 of the following high-grade gliomas: - Glioblastoma multiforme.
  • - Anaplastic astrocytoma.
  • - Gliosarcoma.
  • - Disease in first relapse.
  • - No primary brainstem or spinal cord gliomas.
  • - No secondary glioblastomas arising after prior treatment for a non-glial tumor.
  • - Prior local radiotherapy of 5,000-6,000 cGy required.
  • - Less than 1.5 cm of residual gadolinium-enhancing tumor in maximal cross-sectional diameter by MRI.
  • - No metastatic tumor by spinal MRI.
PATIENT CHARACTERISTICS: Age.
  • - Under 21 at diagnosis.
Performance status.
  • - Lansky 50-100% OR.
  • - Karnofsky 50-100% Life expectancy.
  • - Not specified.
Hematopoietic.
  • - Absolute neutrophil count ≥ 500/mm^3.
  • - Platelet count ≥ 100,000/mm^3 (transfusion independent) Hepatic.
  • - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST or ALT < 2.5 times ULN.
Renal.
  • - Glomerular filtration rate ≥ 60 mL/min AND/OR.
  • - Creatinine clearance ≥ 60 mL/min.
Cardiovascular.
  • - Shortening fraction ≥ 27% by echocardiogram OR.
  • - Ejection fraction ≥ 50% by MUGA.
Pulmonary.
  • - No dyspnea at rest.
  • - No exercise intolerance.
  • - Pulse oximetry > 94% Other.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - Not specified.
Chemotherapy.
  • - More than 4 weeks since prior chemotherapy.
  • - No prior thiotepa.
  • - No prior myeloablative chemotherapy.
Endocrine therapy.
  • - No concurrent corticosteroids.
Radiotherapy.
  • - See Disease Characteristics.
  • - More than 8 weeks since prior radiotherapy.
  • - No prior craniospinal radiotherapy.
Surgery. - Not specified

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00078988
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Children's Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ziad Khatib, MDSharon L. Gardner, MD
Principal Investigator Affiliation Nicklaus Children's Hospital f/k/a Miami Children's HospitalNYU Langone Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries Australia, Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Tumor, Central Nervous System Tumor
Additional Details

OBJECTIVES:

  • - Compare the event-free survival and overall survival of pediatric patients with recurrent high-grade gliomas treated with a single course of high-dose carboplatin, etoposide, and thiotepa and autologous stem cell transplantation vs.#46;multiple courses of intermediate-dose carboplatin and thiotepa and autologous stem cell transplantation with or without isotretinoin.
  • - Compare the number of hospital days and time to engraftment in patients treated with these regimens.
  • - Compare the toxic death rate in patients treated with these regimens.
  • - Compare the tolerability of isotretinoin in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to pathologic diagnosis (glioblastoma multiforme vs.#46;anaplastic astrocytoma vs.#46;other high-grade glioma).
  • - Chemotherapy and autologous stem cell reinfusion (ASCR): Patients are randomized to 1 of 2 treatment arms.
  • - Arm I (high-dose chemotherapy and ASCR): Patients receive high-dose chemotherapy comprising carboplatin IV over 4 hours on days -8 to -6; thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3; and filgrastim (G-CSF) IV or subcutaneously (SC) once daily beginning on day 1 and continuing until blood counts recover.
Autologous peripheral blood stem cells (PBSC) or bone marrow are reinfused on day 0.
  • - Arm II (intermediate-dose chemotherapy and ASCR): Patients receive intermediate-dose chemotherapy comprising carboplatin IV over 4 hours and thiotepa IV over 3 hours on days 1-2 and G-CSF IV or SC once daily beginning on day 4 and continuing until blood counts recover.
Autologous PBSC or bone marrow are reinfused on day 3. Treatment repeats every 28 days for a total of 3 courses.
  • - Maintenance therapy: After recovery from chemotherapy (approximately day 30 post-transplantation), all patients are further randomized to 1 of 2 maintenance arms.
  • - Arm I: Patients receive oral isotretinoin twice daily on days 1-14.
Treatment repeats every 28 days for a total of 6 courses.
  • - Arm II: Patients do not receive maintenance therapy.
In all arms, treatment continues in the absence of disease progression. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 80-150 patients (40-75 per treatment arm) will be accrued for this study within 5 years.

Arms & Interventions

Arms

Experimental: Arm I (high-dose chemotherapy and ASCR)

Patients receive high-dose chemotherapy comprising carboplatin IV over 4 hours on days -8 to -6; thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3; and filgrastim (G-CSF) IV or SC once daily beginning on day 1 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 0.

Experimental: Arm II (intermediate-dose chemotherapy and ASCR)

Patients receive intermediate-dose chemotherapy comprising carboplatin IV over 4 hours and thiotepa IV over 3 hours on days 1-2 and G-CSF IV or SC once daily beginning on day 4 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 3. Treatment repeats every 28 days for a total of 3 courses.

Experimental: Arm III (isotretinoin)

Patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for a total of 6 courses.

No Intervention: Arm IV (no isotretinoin)

Patients do not receive maintenance therapy.

Interventions

Biological: - filgrastim

Given IV

Drug: - carboplatin

Given IV

Drug: - etoposide

Given IV

Drug: - isotretinoin

Given IV

Drug: - thiotepa

Given IV

Procedure: - autologous bone marrow transplantation

Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)

Procedure: - peripheral blood stem cell transplantation

Filgrastim is to be given daily in the afternoon for 4 days prior to the first harvest and continued until the completion of the daily harvests. The daily PBSC harvesting should be started prior to the fifth dose of filgrastim.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Cancer Center, Denver, Colorado

Status

Address

Children's Hospital Cancer Center

Denver, Colorado, 80218-1088

San Diego, California

Status

Address

Children's Hospital and Health Center - San Diego

San Diego, California, 92123-4282

Little Rock, Arkansas

Status

Address

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

Oakland, California

Status

Address

Children's Hospital and Research Center - Oakland

Oakland, California, 94609-1809

Sacramento, California

Status

Address

University of California Davis Cancer Center

Sacramento, California, 95817

Children's National Medical Center, Washington, District of Columbia

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Address

Children's National Medical Center

Washington, District of Columbia, 20010-2970

Gainesville, Florida

Status

Address

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232

Nemours Children's Clinic, Jacksonville, Florida

Status

Address

Nemours Children's Clinic

Jacksonville, Florida, 32207

Miami, Florida

Status

Address

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Miami Children's Hospital, Miami, Florida

Status

Address

Miami Children's Hospital

Miami, Florida, 33155

All Children's Hospital, St. Petersburg, Florida

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Address

All Children's Hospital

St. Petersburg, Florida, 33701

Tampa, Florida

Status

Address

St. Joseph's Cancer Institute at St. Joseph's Hospital

Tampa, Florida, 33607

West Palm Beach, Florida

Status

Address

Kaplan Cancer Center at St. Mary's Medical Center

West Palm Beach, Florida, 33407

Emory University Hospital - Atlanta, Atlanta, Georgia

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Address

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322

Cancer Research Center of Hawaii, Honolulu, Hawaii

Status

Address

Cancer Research Center of Hawaii

Honolulu, Hawaii, 95813

Indiana University Cancer Center, Indianapolis, Indiana

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Address

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289

St. Vincent Indianapolis Hospital, Indianapolis, Indiana

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Address

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

Kosair Children's Hospital, Louisville, Kentucky

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Address

Kosair Children's Hospital

Louisville, Kentucky, 40232

Bangor, Maine

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Address

CancerCare of Maine at Eastern Maine Medial Center

Bangor, Maine, 04401

Boston, Massachusetts

Status

Address

Floating Hospital for Children at Tufts - New England Medical Center

Boston, Massachusetts, 02111

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379

Grand Rapids, Michigan

Status

Address

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503-2560

Grosse Pointe Woods, Michigan

Status

Address

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236

Minneapolis, Minnesota

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Address

Children's Hospital of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Minneapolis, Minnesota

Status

Address

Fairview University Medical Center - University Campus

Minneapolis, Minnesota, 55455

University of Mississippi Medical Center, Jackson, Mississippi

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Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505

Children's Mercy Hospital, Kansas City, Missouri

Status

Address

Children's Mercy Hospital

Kansas City, Missouri, 64108

St. Louis, Missouri

Status

Address

Siteman Cancer Center at Barnes-Jewish Hospital

St. Louis, Missouri, 63110

New Brunswick, New Jersey

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Address

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001

New York, New York

Status

Address

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016

New York, New York

Status

Address

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032

Rochester, New York

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Address

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642

SUNY Upstate Medical University Hospital, Syracuse, New York

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Address

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210

New York Medical College, Valhalla, New York

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Address

New York Medical College

Valhalla, New York, 10595

Akron, Ohio

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Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062

Cincinnati, Ohio

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Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039

Rainbow Babies and Children's Hospital, Cleveland, Ohio

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Address

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-5000

Columbus Children's Hospital, Columbus, Ohio

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Address

Columbus Children's Hospital

Columbus, Ohio, 43205-2696

Children's Medical Center - Dayton, Dayton, Ohio

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Address

Children's Medical Center - Dayton

Dayton, Ohio, 45404-1815

Oklahoma University Medical Center, Oklahoma City, Oklahoma

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Address

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104

Hershey, Pennsylvania

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Address

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850

Charleston, South Carolina

Status

Address

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425

Sioux Falls, South Dakota

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Address

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039

Fort Worth, Texas

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Address

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104-9958

Covenant Children's Hospital, Lubbock, Texas

Status

Address

Covenant Children's Hospital

Lubbock, Texas, 79410

Primary Children's Medical Center, Salt Lake City, Utah

Status

Address

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100

INOVA Fairfax Hospital, Fairfax, Virginia

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Address

INOVA Fairfax Hospital

Fairfax, Virginia, 22031

Norfolk, Virginia

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Address

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507-1971

Richmond, Virginia

Status

Address

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0037

Madison, Wisconsin

Status

Address

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin

Status

Address

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449

International Sites

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Status

Address

Princess Margaret Hospital for Children

Perth, Western Australia, 6001

Vancouver, British Columbia, Canada

Status

Address

Children's & Women's Hospital of British Columbia

Vancouver, British Columbia, V6H 3V4

Hamilton, Ontario, Canada

Status

Address

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Montreal, Quebec, Canada

Status

Address

Montreal Children's Hospital at McGill University Health Center

Montreal, Quebec, H3H 1P3

Hopital Sainte Justine, Montreal, Quebec, Canada

Status

Address

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5

Ste-Foy, Quebec, Canada

Status

Address

Centre Hospitalier Universitaire de Quebec

Ste-Foy, Quebec, G1V 4G2

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