Trial Information

Hodgkins Disease Study

OBJECTIVES:

- Establish a uniform practice for the management of children with Hodgkin's lymphoma.

- Document the long-term side effects of such management.

- Establish whether or not children can be safely managed without staging laparotomy and
splenectomy.

- Establish whether or not chlorambucil, vinblastine, procarbazine hydrochloride, and
prednisolone (CLVPP) is an effective alternative to mechlorethamine, vincristine,
procarbazine hydrochloride, and prednisone (MOPP) chemotherapy.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment regimens
according to disease stage and presence of bulky mediastinal disease.

- Involved-field radiotherapy (for patients with stage IA [nodal] disease): Patients
undergo involved-field radiotherapy 5 days a week for 4 weeks.

- CLVPP chemotherapy (for patients with all other stages of disease AND no bulky
mediastinal disease): Patients receive CLVPP chemotherapy comprising oral chlorambucil,
oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV
on days 1 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of
disease progression or unacceptable toxicity.

- CLVPP chemotherapy and radiotherapy (for patients with all other stages of disease AND
bulky mediastinal disease): Patients receive CLVPP chemotherapy as above. Patients then
undergo radiotherapy to the mediastinum beginning 2 weeks after completing the last
course of CLVPP chemotherapy.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 358 patients were accrued for this study.