Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

294

Study ID:

NCT00002827

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 39 Locations for this study

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Long Beach Memorial Medical Center
Long Beach California, 90806, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Children's Hospital of Orange County
Orange California, 92668, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, 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, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, 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, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Kaplan Cancer Center
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Veterans Affairs Medical Center - Fargo
Fargo North Dakota, 58102, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati Ohio, 45229, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Children's Hospital of Columbus
Columbus Ohio, 43205, United States
Doernbecher Children's Hospital
Portland Oregon, 97201, 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, 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
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Princess Margaret Hospital for Children
Perth Western Australia, 6001, Australia
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
IWK Grace Health Centre
Halifax Nova Scotia, B3J 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

294

Study ID:

NCT00002827

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

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