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

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Lenograstim; Liposomal doxorubicin; Prednisone; Vincristine; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically confirmed Hodgkin's lymphoma meeting the following criteria:

• Newly diagnosed disease

• Stage IA OR stage IIA without bulky disease

• No lymphocyte-predominant histology

• Staging on this study will be determined by the clinical stage; surgical staging is strongly discouraged, except for the rare situation of equivocal imaging studies below the diaphragm

• Patients may not have received any previous chemotherapy or radiation therapy; patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol; steroids used for treatment of contrast agent allergy required for computed tomography (CT) scans are acceptable

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^3

• Total bilirubin =< 1.5 x normal

• Alanine (ALT) =< 2.5 x normal

• Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by multi-gated acquisition (MUGA)

• No pathologic prolongation of QTc interval on 12-lead electrocardiography (ECG)

• Female patients of childbearing potential must have a negative pregnancy test

• Lactating females must agree that they will not breastfeed a child while on this study

• Fertile patients must use effective contraception

• Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

• All patients and/or their parents or legal guardians must sign a written informed consent

• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met