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OpenTrials
Completed

NCT Number: NCT00005578

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bleomycin sulfate

Biological

Other names: Blenoxane, NSC #125066

filgrastim

Biological

Other names: GRANULOCYTE-COLONY STIMULATING FACTOR, r-metHuG-CSF, G-CSF, Neupogen, NSC #614629

Cyclophosphamide

Drug

Other names: CTX, Cytoxan, NSC #26271

Dexrazoxane Hydrochloride

Drug

Other names: DZR, ADR-529, ZINECARD, ICRF-187, NSC #169780

Doxorubicin hydrochloride

Drug

Other names: Adriamycin, NSC #123127

etoposide

Drug

Other names: VP-16, VePesid, NSC #141540

Prednisone

Drug

Other names: Deltasone, Meticorten, Liquid Pred, NSC #10023

vincristine sulfate

Drug

Other names: VCR, Oncovin, NSC #67574

radiation therapy

Radiation

Primary outcomes

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

    Time frame: One year post therapy

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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2004
Study completion
2008
First posted
May 26, 2004
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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