Trial Information

Hodgkin's Disease Study

OBJECTIVES:

- Maintain the present satisfactory results of patients treated on protocol
UKCCSG-HD-8201 in pediatric patients with stage I-III Hodgkin's lymphoma treated with
radiotherapy or combination chemotherapy comprising chlorambucil, procarbazine
hydrochloride, prednisolone, vinblastine followed by doxorubicin hydrochloride,
bleomycin, vincristine, and dacarbazine.

- Determine, by comparison with UKCCSG-HD-8201, if mediastinal irradiation can be safely
omitted from the management of pediatric patients with Hodgkin's lymphoma and bulky
mediastinal disease.

- Determine if gallium scanning of the mediastinum after chemotherapy will identify
patients with residual active mediastinal disease.

- Improve disease control in patients with stage IV Hodgkin's lymphoma and slow
responders by intensifying treatment to patients who fail to achieve complete remission
after 4 courses of chlorambucil, vinblastine, procarbazine hydrochloride, and
prednisone.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease
(I vs II-IV).

- Stage I: Patients undergo involved-field radiotherapy.

- Stage II-IV:

- CHLVPP chemotherapy: Patients receive CHLVPP chemotherapy comprising oral
chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14
and vinblastine IV on days 1-8. Treatment repeats every 28 days for 2 courses.
Patients achieving complete resolution (CR) of measurable disease receive an
additional 4 courses of CHLVPP. Patients with no response or progressive disease
proceed to ABVD chemotherapy. Patients with shrinkage of measurable disease to <
50% original dimensions (GPR) receive 2 additional courses of CHLVPP. Patients
achieving CR or GPR after completion of 2 additional courses of CHLVPP receive 4
more courses of CHLVPP. Patients achieving shrinkage of measurable disease to ≥
50% of original dimension (PR) after 2 additional courses of CHLVPP OR patients
not achieving CR after a total of 8 courses of CHLVPP proceed to ABVD
chemotherapy.

- ABVD chemotherapy: Patients receive ABVD chemotherapy comprising doxorubicin
hydrochloride IV over 4 hours and bleomycin IV, vincristine IV, and dacarbazine IV
on days 1 and 15. Treatment repeats every 28 days for 4-6 courses in the absence
of disease progression or unacceptable toxicity.

- Mediastinal mass: Patients receive chemotherapy as per stages II-IV. Patients
presenting with airway or superior vena cava obstruction may also undergo radiotherapy.
Patients achieving CR after completion of chemotherapy receive no further treatment.
Patients achieving GPR or PR after completion of chemotherapy undergo gallium scan and
CT scan of thorax with or without biopsy at the investigator's discretion.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 353 patients were accrued for this study.