Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-20

Study Completion Date

2022-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

NCT01026220

Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma Stage III Childhood Hodgkin Lymphoma Stage IV Childhood Hodgkin Lymphoma

COMPLETED PHASE3

Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma

NCT00302003

Childhood Favorable Prognosis Hodgkin Lymphoma Childhood Lymphocyte Depletion Hodgkin Lymphoma Childhood Mixed Cellularity Hodgkin Lymphoma +3 more

COMPLETED PHASE3

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma

NCT00846742

Hodgkin Lymphoma

ACTIVE_NOT_RECRUITING PHASE2

Therapy for Pediatric Hodgkin Lymphoma

NCT00145600

Hodgkin Lymphoma

COMPLETED PHASE2

Combination Chemotherapy With or Without Radiation Therapy and Peripheral Stem Cell Transplant in Treating Children With Hodgkin's Lymphoma

NCT00025064

Lymphoma

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hodgkin's Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All Participants

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.

Group Type EXPERIMENTAL

Adriamycin®

Intervention Type DRUG

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

Vinblastine

Intervention Type DRUG

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

Nitrogen Mustard

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Vincristine

Intervention Type DRUG

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

Bleomycin

Intervention Type DRUG

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

Etoposide

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

Given PO every other day of weeks 1-12.

G-CSF

Intervention Type BIOLOGICAL

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

Radiotherapy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adriamycin®

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

Intervention Type DRUG

Vinblastine

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

Intervention Type DRUG

Nitrogen Mustard

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Vincristine

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

Intervention Type DRUG

Bleomycin

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

Intervention Type DRUG

Etoposide

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

Intervention Type DRUG

Prednisone

Given PO every other day of weeks 1-12.

Intervention Type DRUG

G-CSF

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

Intervention Type BIOLOGICAL

Radiotherapy

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Doxorubicin Velban® Mustargen® Mechlorethamine Hydrochloride Nitrogen Mustard Derivative Velban® Blenoxane® VP-16 Vepesid® Synthetic congener of hydrocortisone Filgrastim Neupogen® Radiation therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.