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Summary

for people ages 1 month to 21 years (full criteria)
at Oakland, California and other locations
study started

Description

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)

Details

PRIMARY OBJECTIVES:

  1. 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.

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.

Keywords

Childhood Lymphocyte Predominant Hodgkin Lymphoma Stage I Childhood Hodgkin Lymphoma Stage II Childhood Hodgkin Lymphoma Lymphoma Hodgkin Disease Cyclophosphamide Liposomal doxorubicin Doxorubicin Prednisone Vincristine

Eligibility

For people ages 1 month to 21 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)
  • For patients that will receive chemotherapy, 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

  • Children's Hospital and Research Center at Oakland
    Oakland, California, 94609-1809, United States
  • Kaiser Permanente-Oakland
    Oakland, California, 94611, United States
  • Sutter General Hospital
    Sacramento, California, 95816, United States
  • City of Hope Medical Center
    Duarte, California, 91010, United States
  • Miller Children's Hospital
    Long Beach, California, 90806, United States
  • Childrens Hospital of Orange County
    Orange, California, 92868-3874, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT00107198
Study Type
Interventional
Last Updated
December 20, 2016