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


N/A
1 Month
21 Years
Open (Enrolling)
Both
Childhood Lymphocyte Predominant Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma

Thank you

Trial Information

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


PRIMARY OBJECTIVES:

I. To preserve the excellent cure rate in patients with lymphocyte predominant Hodgkin
disease (LPHD) while employing a treatment strategy that minimizes the exposure to
chemotherapy and radiation therapy in appropriate patients.

II. To estimate the proportion of stage I patients (with a single involved lymph node that
is totally resected) who can be cured with surgery alone.

III. To estimate the proportions of stage I unresected, stage I resected (whose disease has
recurred after observation), and stage II LPHD patients who can be cured with adriamycin
(doxorubicin)/vincristine/prednisone/cyclophosphamide (AV-PC) x 3, with involved field
radiation therapy (IFRT) for those who are not in a CR after chemotherapy.

IV. To reduce the potential for long-term toxicity of LPHD treatment.

OUTLINE: This is a pilot study.

Patients with stage IA disease who underwent confirmed complete resection of a single
involved lymph node at diagnosis undergo observation only*.

Patients with stage IA disease who underwent possible complete resection of a single
involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery. Patients with a
confirmed complete resection by imaging undergo observation only*. Patients who do not
demonstrate complete resection by imaging proceed to combination chemotherapy with or
without radiotherapy.

Patients with stage IA disease who underwent a fine needle aspiration of a single involved
lymph node OR an incomplete resection of a single involved lymph node at diagnosis may
undergo a second surgery to achieve complete resection. Patients who undergo complete
resection during the second surgery undergo imaging at 6-7 weeks after surgery. Patients
with a confirmed complete resection by imaging undergo observation only*. Patients who do
not undergo a second surgery OR do not achieve complete resection with the second surgery
proceed to combination chemotherapy with or without radiotherapy. Patients with stage IA
disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to
combination chemotherapy with or without radiotherapy.

NOTE: *Patients with recurrent disease after observation only undergo biopsy and restaging
and then proceed to combination chemotherapy with or without radiotherapy. (AS OF AMENDMENT
#4, THE TREATMENT ARM FOR PATIENTS WHOSE CANCER RECURRED AFTER OBSERVATION ALONE IS NOW
CLOSED)

COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (IV) over
10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on
days 1 and 8, and prednisone orally (PO) or IV two or three times daily on days 1-7.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity. Patients who achieve complete response (CR) after 3 courses of
therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field
radiotherapy.

INVOLVED-FIELD RADIOTHERAPY (IFRT): Beginning within 3 weeks after completion of combination
chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).

Patients are followed every 3 months for 2 years, every 6 months for 3 years, annually for 5
years, and then every 5 years for 10 years.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Failure-free survival (FFS) rate

Outcome Description:

The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: Disseminated disease (> Stage I/II) progression or recurrence at any time. Local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT. Occurrence of a second malignant neoplasm. Death from any cause.

Outcome Time Frame:

At 5 years

Safety Issue:

No

Principal Investigator

Burton Appel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

AHOD03P1

NCT ID:

NCT00107198

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Childhood Lymphocyte Predominant Hodgkin Lymphoma
  • Stage I Childhood Hodgkin Lymphoma
  • Stage II Childhood Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Johns Hopkins UniversityBaltimore, Maryland  21205
Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Hurley Medical CenterFlint, Michigan  48503
Rhode Island HospitalProvidence, Rhode Island  02903
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
New York Medical CollegeValhalla, New York  10595
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Eastern Maine Medical CenterBangor, Maine  04401
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
Driscoll Children's HospitalCorpus Christi, Texas  78466
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Covenant Children's HospitalLubbock, Texas  79410
Overlook HospitalSummit, New Jersey  07902-0220
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central TexasAustin, Texas  78723
Children's Hospital and Research Center at OaklandOakland, California  94609-1809
City of Hope Medical CenterDuarte, California  91010
Presbyterian HospitalCharlotte, North Carolina  28233-3549
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of North CarolinaChapel Hill, North Carolina  27599
University of FloridaGainesville, Florida  32610-0277
University of RochesterRochester, New York  14642
Yale UniversityNew Haven, Connecticut  06520
University of Arizona Health Sciences CenterTucson, Arizona  85724
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Indiana University Medical CenterIndianapolis, Indiana  46202
University of Texas Southwestern Medical CenterDallas, Texas  
University of KentuckyLexington, Kentucky  40536-0098
Oregon Health and Science UniversityPortland, Oregon  97201
Memorial Health University Medical CenterSavannah, Georgia  31404
M D Anderson Cancer CenterHouston, Texas  77030
Seattle Children's HospitalSeattle, Washington  98105
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Childrens Memorial HospitalChicago, Illinois  60614
Kaiser Permanente-OaklandOakland, California  94611
Sutter General HospitalSacramento, California  95816
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
University of HawaiiHonolulu, Hawaii  96813
Michigan State University - Breslin Cancer CenterEast Lansing, Michigan  48824-1313
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Kalamazoo Center for Medical StudiesKalamazoo, Michigan  49008
State University of New York Upstate Medical UniversitySyracuse, New York  13210
University of IllinoisChicago, Illinois  60612
Memorial Healthcare System - Joe DiMaggio Children's HospitalHollywood, Florida  33021
East Carolina UniversityGreenville, North Carolina  27858
West Virginia University CharlestonCharleston, West Virginia  25304
Advocate Lutheran General HospitalPark Ridge, Illinois  60068
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
C S Mott Children's HospitalAnn Arbor, Michigan  48109
Southern Illinois UniversitySpringfield, Illinois  62702
UMDNJ - Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Phoenix Childrens HospitalPhoenix, Arizona  85016
Miller Children's HospitalLong Beach, California  90806
Childrens Hospital of Orange CountyOrange, California  92868-3874
Nemours Children's Clinic - JacksonvilleJacksonville, Florida  32207-8426
Nemours Childrens Clinic - OrlandoOrlando, Florida  32806
Children's Healthcare of Atlanta - EglestonAtlanta, Georgia  30322
Rainbow Babies and Childrens HospitalCleveland, Ohio  44106
Penn State Hershey Children's HospitalHershey, Pennsylvania  17033
Palmetto Health RichlandColumbia, South Carolina  29203
Childrens Hospital-King's DaughtersNorfolk, Virginia  23507
Children's Hospital ColoradoAurora, Colorado  80045
Greenville Cancer Treatment CenterGreenville, South Carolina  29605
Sanford USD Medical Center - Sioux FallsSioux Falls, South Dakota  57117-5134
T C Thompson Children's HospitalChattanooga, Tennessee  37403
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, New York  11040