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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00107198
First received: April 5, 2005
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Childhood Lymphocyte Predominant Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Drug: doxorubicin hydrochloride
Procedure: conventional surgery
Drug: cyclophosphamide
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Failure-free survival (FFS) rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Survival rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Cure by surgery alone in Stage I resected patients [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I unresected, Stage I resected whose disease recurred, and Stage II patients [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Grade 3 or 4 toxicity [ Time Frame: any time during chemoradiotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 188
Study Start Date: January 2006
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery or combination chemotherapy, with/without radiotherapy

SURGERY: Patients with Stage IA disease present in a single node that is completely resected are observed for relapse without chemotherapy

COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day 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 CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).

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).

Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: prednisone
Given IV or PO
Other Names:
  • DeCortin
  • Deltra
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Radiation: radiation therapy
Undergo IFRT
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 oxaloacetic 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107198

  Show 102 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Burton Appel, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00107198     History of Changes
Other Study ID Numbers: AHOD03P1, NCI-2009-00376, COG-AHOD03P1, CDR0000419921, U10CA098543
Study First Received: April 5, 2005
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 20, 2014