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Cardiac ToxicityPhase 3NCT00005578

Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease

A Phase 3 study testing bleomycin sulfate, filgrastim and cyclophosphamide in people with Cardiac Toxicity and Lymphoma, run by Children's Oncology Group at 63 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Cardiac Toxicity, Lymphoma
What is being tested?
bleomycin sulfate, filgrastim and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
63 sitesin 3 countries
Study dates
Mar 1997to Jun 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease of the following stages: Stages IIB, IIIB or IV

PATIENT CHARACTERISTICS: Age: 21 or under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times upper normal limit Renal: Not specified Other: Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Less than one week of steroids for management of airway complications Radiotherapy: No prior radiotherapy except emergency radiation to the mediastinum Surgery: Not specified

Trial locations and contacts

63 sites in 3 countries.

63 sites in 3 countries

United States57 sites

  • Memorial Mission Hospital

    Asheville, North Carolina, 28801

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Boston Floating Hospital Infants and Children

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233-3549

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia, 22908

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Shands Hospital and Clinics, University of Florida

    Gainesville, Florida, 32610-100277

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • MBCCOP - University of South Alabama

    Mobile, Alabama, 36688

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Oklahoma Memorial Hospital

    Oklahoma City, Oklahoma, 73126-0307

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • MBCCOP - South Texas Pediatric

    San Antonio, Texas, 78284-7810

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • CCOP - Florida Pediatric

    Tampa, Florida, 33682-7757

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada5 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McMaster Division

    Hamilton, Ontario, L8N 3Z5

  • Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Switzerland1 site

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

Other trials in Switzerland

About this study

Official title: Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.

Read the detailed description

OBJECTIVES: I. Determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide (DBVE-PC) with filgrastim (G-CSF) followed by consolidative radiotherapy in children with advanced stage Hodgkin's disease. II. Tailor therapy based on rapidity of response in order to minimize cumulative drug dosages. III. Compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without compromising response.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs. Patients assigned to arm II receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm I. Patients who exhibit a complete remission (CR) or provisional CR then receive radiotherapy to the regional field 5 days a week for 2.8 weeks. If the disease is not responsive, 2 more courses of chemotherapy are given. Patients whose disease remains nonresponsive or progresses go off the study. Radiotherapy may follow for others. Patients are followed every 3 months for the first year, every 4 months for the second year, every 6 months for the third year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 277 patients will be accrued for this study within 3 years.

Being tested
bleomycin sulfate, filgrastim, cyclophosphamide, dexrazoxane hydrochloride, doxorubicin hydrochloride
Keywords
stage II childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, cardiac toxicity
Medical subject headings
Cardiotoxicity, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bleomycin sulfateBiological

    Also called Blenoxane, NSC #125066

  • filgrastimBiological

    Also called GRANULOCYTE-COLONY STIMULATING FACTOR, r-metHuG-CSF, G-CSF, Neupogen

  • cyclophosphamideDrug

    Also called CTX, Cytoxan, NSC #26271

  • dexrazoxane hydrochlorideDrug

    Also called DZR, ADR-529, ZINECARD, ICRF-187

  • doxorubicin hydrochlorideDrug

    Also called Adriamycin, NSC #123127

  • etoposideDrug

    Also called VP-16, VePesid, NSC #141540

  • prednisoneDrug

    Also called Deltasone, Meticorten, Liquid Pred, NSC #10023

  • vincristine sulfateDrug

    Also called VCR, Oncovin, NSC #67574

  • radiation therapyRadiation

Study groups in NCT00005578
Study groupRoleWhat they receive
Arm 1ExperimentalPatients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin hydrochloride and etoposide on days 0 and 1, bleomycin sulfate and vincristine sulfate on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs.
Receives: Biological: bleomycin sulfate; Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy
Arm 2ExperimentalPatients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin hydrochloride and etoposide on days 0 and 1, bleomycin sulfate and vincristine sulfate on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Dexrazoxane hydrochloride on days 0, 1, and 7
Receives: Biological: bleomycin sulfate; Biological: filgrastim; Drug: cyclophosphamide; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diffusing capacity of the lungs for carbon monoxide (DLCO)

    The Wilcoxon test will be used to evaluate whether DLCO values differ between the two arms.

    Measured: One year post therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2004 (estimated)
  2. Study startMar 1997
  3. Primary completionOct 2004
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005578
Sponsor's protocol ID
9425
Other IDs
COG-9425, CDR0000065359, P9425
Status last verified
Jul 2014
First submitted
2 May 2000
Last updated
24 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Tebbi CK, London WB, Friedman D, Villaluna D, De Alarcon PA, Constine LS, Mendenhall NP, Sposto R, Chauvenet A, Schwartz CL. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol. 2007 Feb 10;25(5):493-500. doi: 10.1200/JCO.2005.02.3879.

    PubMed 17290056

  • Schwartz CL, Tebbi CK, Constine LS: Response based therapy for pediatric Hodgkin's disease (HD): Pediatric Oncology Group (POG) protocols 9425/9426. [Abstract] Med Pediatr Oncol 37 (3): A-P219, 263, 2001.

  • Voss SD, Chen L, Constine LS, Chauvenet A, Fitzgerald TJ, Kaste SC, Slovis T, Schwartz CL. Surveillance computed tomography imaging and detection of relapse in intermediate- and advanced-stage pediatric Hodgkin's lymphoma: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2635-40. doi: 10.1200/JCO.2011.40.7841. Epub 2012 Jun 11.

    PubMed 22689804

  • Schwartz CL, Constine LS, Villaluna D, London WB, Hutchison RE, Sposto R, Lipshultz SE, Turner CS, deAlarcon PA, Chauvenet A. A risk-adapted, response-based approach using ABVE-PC for children and adolescents with intermediate- and high-risk Hodgkin lymphoma: the results of P9425. Blood. 2009 Sep 3;114(10):2051-9. doi: 10.1182/blood-2008-10-184143. Epub 2009 Jul 7.

    PubMed 19584400

  • Constine LS, Marcus R, Chauvenet A, et al.: Patterns of failure after response-based, dose-dense therapy for intermediate/high risk pediatric Hodgkin's disease (POG 9425). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-37, S21, 2005.

  • Schwartz CL, Constine LS, London W, et al.: POG 9425: response-based, intensively timed therapy for intermediate/high stage (IS/HS) pediatric Hodgkin's disease. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1555, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bleomycin sulfate, filgrastim and cyclophosphamide in people with Cardiac Toxicity and Lymphoma, run by Children's Oncology Group at 63 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diffusing capacity of the lungs for carbon monoxide (DLCO) (time frame: One year post therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005578, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.

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