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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005578 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Toxicity Lymphoma |
Biological: bleomycin sulfate Biological: filgrastim Drug: cyclophosphamide Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study |
| Study Start Date: | March 1997 |
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - University of South Alabama | |
| Mobile, Alabama, United States, 36688 | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Lucile Packard Children's Hospital at Stanford | |
| Palo Alto, California, United States, 94304 | |
| University of California Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| CCOP - Florida Pediatric | |
| Tampa, Florida, United States, 33682-7757 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| Shands Hospital and Clinics, University of Florida | |
| Gainesville, Florida, United States, 32610-100277 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Children's Memorial Hospital, Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| MBCCOP - LSU Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Ochsner Clinic | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231 | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Boston Floating Hospital Infants and Children | |
| Boston, Massachusetts, United States, 02111 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11042 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Memorial Mission Hospital | |
| Asheville, North Carolina, United States, 28801 | |
| Presbyterian Healthcare | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, Oklahoma | |
| Oklahoma Memorial Hospital | |
| Oklahoma City, Oklahoma, United States, 73126-0307 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Children's Hospital of Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| MBCCOP - South Texas Pediatric | |
| San Antonio, Texas, United States, 78284-7810 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Virginia | |
| Cancer Center, University of Virginia HSC | |
| Charlottesville, Virginia, United States, 22908 | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Naval Medical Center, Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| United States, Wisconsin | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| McMaster Division | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Montreal Children's Hospital | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, CH 3010 | |
| Study Chair: | Cindy Schwartz, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000065359, COG-9425 |
| Study First Received: | May 2, 2000 |
| Last Updated: | July 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005578 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma cardiac toxicity |
|
Anti-Inflammatory Agents Prednisone Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Razoxane Therapeutic Uses Etoposide Lymphoma Hodgkin Disease |
Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Antimitotic Agents Cardiovascular Agents Glucocorticoids Bleomycin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Lymphatic Diseases |