Trial Information

Phase II Study Evaluating the Toxicity and Efficacy of a Modified German Paediatric Hodgkin's Lymphoma Protocol (HD95) in Young Adults (Aged 18-30 Years) With Hodgkin's Lymphoma

OBJECTIVES:

Primary

- To establish neurotoxicity of OEPA+COPP chemotherapy in young adults.

Secondary

- To determine response rates in patients treated with this regimen.

- To determine disease-free survival of patients treated with this regimen.

- To determine overall survival of patients treated with this regimen.

- To determine gonadal toxicity in patients treated with this regimen.

OUTLINE: Patients are assigned to treatment group according to stage.

- Group 1 (patients with stage 1A, 1B, or 2A disease): Patients receive OEPA chemotherapy
comprising vincristine IV on days 1, 8, and 15; oral prednisolone on days 1-15;
etoposide IV on days 1-5; and doxorubicin hydrochloride IV on days 1 and 15. Courses
repeat every 28 days for 2 courses. Patients achieving a partial response also undergo
radiotherapy after completion of chemotherapy; patients achieving a complete response
do not undergo radiotherapy.

- Group 2 (patients with stage 2AE, 2B, or 3A disease): Patients receive 2 courses of
OEPA chemotherapy as in group 1. Patients then receive COPP chemotherapy comprising
cyclophosphamide IV on days 1 and 8; vincristine IV on days 1 and 8; oral procarbazine
hydrochloride on days 1-15; and oral prednisolone on days 1-15. Courses repeat every 28
days for 2 courses. Patients also undergo radiotherapy after completion of
chemotherapy.

- Group 3 (patients with stage 2BE, 3AE, 3BE, 3B, 4A, or 4B disease): Patients receive 2
courses of OEPA chemotherapy as in group 1. Patients then receive COPP chemotherapy as
in group 2. Treatment with COPP chemotherapy repeats every 28 days for 4 courses.
Patients also undergo radiotherapy after completion of chemotherapy.

In all groups, treatment continues in the absence of disease progression or unacceptable
toxicity.

After completion of study therapy, patients are followed periodically.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.