Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma

Summary

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, 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 brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

Conditions

• Stage II Childhood Hodgkin Lymphoma
• Stage III Childhood Hodgkin Lymphoma
• Stage IV Childhood Hodgkin Lymphoma

Interventions

DRUG

brentuximab vedotin

Given intravenously (IV).

DRUG

etoposide

Given IV.

DRUG

prednisone

Given orally (PO).

DRUG

doxorubicin

Given IV.

DRUG

cyclophosphamide

Given IV.

DRUG

Dacarbazine(R)

Given IV.

DRUG

filgrastim

Given subcutaneously (SQ) as clinically indicated.

OTHER

quality of life assessment

Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.

RADIATION

radiation therapy

At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.

Sponsors & Collaborators

• Seagen Inc.

  collaborator INDUSTRY

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Matt Ehrhardt, MD · St. Jude Children's Research Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-12

Primary Completion

2020-11-16

Completion

2028-05-31

FDA Drug

Yes

Countries

• United States

Study Locations