DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Toxicity; Lymphoma

Intervention: bleomycin sulfate (Biological); filgrastim (Biological); dexrazoxane hydrochloride (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); vincristine sulfate (Drug); low-LET cobalt-60 gamma ray therapy (Radiation); low-LET electron therapy (Radiation); low-LET photon therapy (Radiation)

Phase: Phase 3

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Cameron K. Tebbi, MD, Study Chair, Affiliation: St. Joseph's Children's Hospital of Tampa
Michael A. Weiner, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.

Clinical Details

Official title: RESPONSE DEPENDENT TREATMENT OF STAGES IA, IIA AND IIIA HODGKIN'S DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD: A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: DLCO

Detailed description: OBJECTIVES: I. Modify chemotherapy courses based on initial response to therapy in children with newly diagnosed stage IA/IIA/IIIA1 Hodgkin's disease. II. Examine the activity of variable courses of doxorubicin, bleomycin, vincristine, and etoposide (DBVE) followed by low-dose involved-field irradiation in these patients. III. Monitor the safety and feasibility of the response-dependent approach and the morbidity and immediate and long-term toxic effects associated with this regimen. IV. Assess whether limited therapy is adequate for patients with an early response. V. Evaluate whether the addition of dexrazoxane can reduce pulmonary toxicity while not significantly reducing the response rate or event-free survival. VI. Evaluate whether the frequency and magnitude of myocardial injury during therapy, as measured by elevated serum cardiac troponin-T, is reduced by the addition of dexrazoxane. OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomly assigned to receive doxorubicin, bleomycin, vincristine, etoposide, and filgrastim with vs. without dexrazoxane. Filgrastim SC begins on days 6-13; no filgrastim is given on day 14 or 15. Filgrastim will restart 2 days after completing therapy and continue until count recovery from expected nadir (ANC greater than 1000 cubic meter after nadir). Courses repeat every 28 days. Those with stable or responding disease after 2-4 courses receive involved-field radiotherapy 5 days per week for 3. 5 weeks. Tanner stage IV/V patients are eligible for randomization based on a front-end institutional agreement and may receive standard-field radiotherapy 5 days per week for up to 11 weeks at the investigator's discretion. Patients are followed yearly until relapse, death, or for a minimum of 10 years. PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study over 5 years.

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease No more than 5 weeks since diagnostic biopsy No B symptoms Clinical/pathologic stages (all histologies) as follows: Stage IA/IIA with mediastinal mass less than one third of chest diameter Stage IIIA limited to spleen or splenic, celiac, or portal nodes and lesions no larger than 6 cm Surgical staging required if: Clinical and imaging findings equivocal Tanner stage IV/V for whom radiotherapy is planned Concurrent registration on protocols POG-8828 (late effects study) and POG- 8829 (epidemiology study) required PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: No hematopoietic disease Hepatic: No liver disease Renal: No renal disease Other: No severe organ or system damage or failure No pregnant or nursing women PRIOR CONCURRENT THERAPY: No prior therapy

Locations and Contacts

British Columbia Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada

Long Beach Memorial Medical Center, Long Beach, California 90806, United States

Children's Hospital Los Angeles, Los Angeles, California 90027-0700, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

Children's Hospital of Orange County, Orange, California 92668, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94115-0128, United States

David Grant Medical Center, Travis Air Force Base, California 94535, United States

Children's Hospital of Denver, Denver, Colorado 80218, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5265, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0752, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Children's Mercy Hospital - Kansas City, Kansas City, Missouri 64108, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States

Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States

Kaplan Cancer Center, New York, New York 10016, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota 58102, United States

IWK Grace Health Centre, Halifax, Nova Scotia B3J 3G9, Canada

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio 45229-3039, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

Children's Hospital of Columbus, Columbus, Ohio 43205-2696, United States

Doernbecher Children's Hospital, Portland, Oregon 97201-3098, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Vanderbilt Cancer Center, Nashville, Tennessee 37232-6838, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Related 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.

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.

Starting date: October 1996
Last updated: August 22, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017