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Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

NCT00352027 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-09-22

Study results available
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Summary

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.

Conditions

  • Hodgkin's Lymphoma

Interventions

DRUG

Adriamycin®

Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.

DRUG

Vinblastine

Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.

DRUG

Nitrogen Mustard

Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.

DRUG

Cyclophosphamide

May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.

DRUG

Vincristine

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

DRUG

Bleomycin

Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.

DRUG

Etoposide

Given IV on Days 1 and 2 of weeks 1-10.

DRUG

Prednisone

Given PO every other day of weeks 1-12.

BIOLOGICAL

G-CSF

Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).

PROCEDURE

Radiotherapy

Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.

Sponsors & Collaborators

Principal Investigators

  • Jamie Flerlage, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-20
Primary Completion
2015-05-31
Completion
2022-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00352027 on ClinicalTrials.gov