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ACTIVE NOT RECRUITING

NCT00107198

PHASE2

Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

Summary

This clinical trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, 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 more than one drug (combination chemotherapy) with or without radiation therapy may kill more cancer cells.

Official title: Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Key Details

Gender

All

Age Range

1 Month - 21 Years

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2006-01-02

Completion Date

2030-12-31

Last Updated

2025-09-18

Healthy Volunteers

Conditions

Ann Arbor Stage I Childhood Hodgkin Lymphoma Ann Arbor Stage II Childhood Hodgkin Lymphoma Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma

Interventions

PROCEDURE

Conventional Surgery

Undergo surgery

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Prednisone

Given IV or PO

RADIATION

Radiation Therapy

Undergo IFRT

DRUG

Vincristine Sulfate

Given IV

Inclusion Criteria: * Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD) are eligible for this protocol as follows: * Diagnosis of LPHD must be made using the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification criteria and will be confirmed by rapid pathology central review * Clinical stages as follows: * Stage IA without bulk disease * Stage IIA without bulk disease * Patients with "B" symptoms or bulk disease are NOT eligible for this study * Slides for rapid central pathology review must be sent to the Biopathology Center (BPC) * Serum glutamic oxalo-acetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 times upper limit of normal (ULN) * Total bilirubin =\< 1.5 times ULN * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min * Creatinine based on age/gender as follows: * No greater than 0.4 mg/dL (for patients 1 to 5 months of age) * No greater than 0.5 mg/dL (for patients 6 to 11 months of age) * No greater than 0.6 mg/dL (for patients 1 year of age) * No greater than 0.8 mg/dL (for patients 2 to 5 years of age) * No greater than 1.0 mg/dL (for patients 6 to 9 years of age) * No greater than 1.2 mg/dL (for patients 10 to 12 years of age) * No greater than 1.4 mg/dL (for female patients \>= 13 years of age) * No greater than 1.5 mg/dL (for male patients 13 to 15 years of age) * No greater than 1.7 mg/dL (for male patients \>= 16 years of age) * Shortening fraction of \>= 27% by echocardiogram or ejection fraction of \>= 50% by multigated radionuclide angiogram (MUGA) * Lactating females must agree that they will not breastfeed a child if they are to receive chemotherapy or radiation treatment\* * Female patients of childbearing potential must have a negative pregnancy test if they are to receive chemotherapy or radiation treatment\* * Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method if they are to receive chemotherapy or radiation treatment\* * Note: \*Pregnant or breastfeeding women with stage I, single involved lymph node and confirmed (by Quality Assurance Review Center \[QARC \]) total resection, are eligible for the observation arm only; no chemotherapy or radiation treatment will be administered to pregnant or breastfeeding women * No prior chemotherapy * More than 30 days since prior systemic corticosteroids * No prior radiotherapy * All patients and/or their parents or legal guardians must sign a written informed consent

Locations (170)

Children's Hospital of Alabama

Birmingham, Alabama, United States

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center

Downey, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Children's Hospital of Orange County

Orange, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

UCSF Medical Center-Parnassus

San Francisco, California, United States

Harbor-University of California at Los Angeles Medical Center

Torrance, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

University of Connecticut

Farmington, Connecticut, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Lee Memorial Health System

Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

AdventHealth Orlando