Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

St. Jude Children's Research Hospital

Status and phase

Completed

Phase 2

Conditions

Hodgkin's Lymphoma

Treatments

Procedure: Radiotherapy

Drug: Adriamycin®

Drug: Bleomycin

Drug: Cyclophosphamide

Drug: Etoposide

Drug: Prednisone

Drug: Vinblastine

Drug: Vincristine

Drug: Nitrogen Mustard

Biological: G-CSF

Study type

Interventional

Funder types

Other

Identifiers

NCT00352027

NCI-2011-01253 (Registry Identifier)

HOD05

Details and patient eligibility

About

The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field radiation therapy. The hypothesis being studied is that this treatment will result in more than 80% of patients being alive and free of disease three years after starting treatment.

Full description

Treatment Plan Description:

Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11

Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9

Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)

Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12

Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11

Prednisone* 40 mg/m2/day divided in 3 doses PO Every other day of weeks 1-12

G-CSF (only as needed in case of severe myelo-suppression requiring treatment delay) 5 mcg/kg SC Days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)

* Prednisone taper is foreseen for the last 2 weeks of therapy. Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above. Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy. The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy: 15 Gy for areas achieving a complete response and 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.

Enrollment

81 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is less than or equal to 21 years of age
Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma
Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal involvement (3 or more sites), or bulky mediastinal adenopathy.

Exclusion criteria

Patients with favorable risk features
Patients with unfavorable risk features
Patients who have received prior therapy for Hodgkin lymphoma.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

81 participants in 1 patient group

All Participants

Experimental group

Description:

Participants receive 12 weeks of Stanford V chemotherapy which includes Adriamycin®, Vinblastine, Nitrogen Mustard (or Cyclophosphamide), Vincristine, Bleomycin, Etoposide, Prednisone, and G-CSF. After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy.

Treatment: