Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
Condition: Ann Arbor Stage I Childhood Hodgkin Lymphoma; Ann Arbor Stage II Childhood Hodgkin Lymphoma; Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Conventional Surgery; Cyclophosphamide; Doxorubicin Hydrochloride; Prednisone; Radiation Therapy; Vincristine Sulfate
Intervention description: Undergo surgery; Given IV; Given IV; Given IV or PO; Undergo IFRT; Given IV
Intervention MeSH terms: Prednisone; Cortisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 1 Month
Maximum age: 21 Years
Healthy volunteers: No

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.
    

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)

          -  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