Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin 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 combination chemotherapy 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: Bleomycin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Liposomal doxorubicin; Prednisone; Vincristine; Vinorelbine

Criteria

Inclusion Criteria:

• Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:

• Classical disease

• Nodular lymphocyte-predominant disease

• Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:

• Unexplained weight loss > 10% within the past 6 months

• Unexplained recurrent fever > 38°C within the past month

• Recurrent drenching night sweats within the past month

• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:

• 0.4 mg/dL (1 to 5 months)

• 0.5 mg/dL (6 to 11 months)

• 0.6 mg/dL (12 to 23 months)

• 0.8 mg/dL (2 to 5 years)

• 1 mg/dL (6 to 9 years)

• 1.2 mg/dL (10 to 12 years)

• 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)

• 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

• AST or ALT < 2.5 times ULN for age

• Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to large mediastinal mass from HL)

• FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)

• For children who are unable to cooperate for PFTs, the criteria are:

• No evidence of dyspnea at rest

• No exercise intolerance

• Pulse oximetry > 92% on room air

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No pathologic prolongation of QTc interval (> 450 milliseconds) on 12-lead ECG

• No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody therapy), or radiotherapy

• At least 28 days since prior corticosteroids except for emergent treatment for respiratory distress or spinal cord compression, or for treatment of allergy to contrast agent required for CT scan

• No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)

• Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic reactions allowed

• No concurrent pegfilgrastim