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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Pathologically confirmed newly diagnosed Hodgkin lymphoma 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 from HL)
- 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

More information

Publications

Publications are currently not available

Clinical Trials