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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 06-002802
    NCT ID: NCT00107198
    Sponsor Protocol Number: AHOD03P1

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola A Arndt, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20308031

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