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Combination Chemotherapy With or Without Radiation Therapy and Peripheral Stem Cell Transplant in Treating Children With Hodgkin's Lymphoma

6. august 2013 opdateret af: Children's Cancer and Leukaemia Group

Protocol For The Treatment Of Children And Adolescents With Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy.

PURPOSE: This phase II trial is studying how well combination chemotherapy regimens with or without radiation therapy or peripheral stem cell transplant works in treating children with Hodgkin's lymphoma.

Studieoversigt

Status

Ukendt

Betingelser

Lymfom

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Determine whether the current survival figures are maintained and long-term sequelae of treatment are minimized in children or adolescents with stage I-III Hodgkin's lymphoma after receiving the following regimen, which reduces exposure to chemotherapy and radiotherapy: chlorambucil, vinblastine, prednisolone, and procarbazine (ChIVPP) and doxorubicin, bleomycin, vincristine, and dacarbazine (ABVD) with etoposide, prednisolone, ifosfamide, and cisplatin (EPIC), radiotherapy, high-dose melphalan, and/or autologous peripheral blood stem cell transplantation (APBSCT).
Determine whether the survival figures are improved in children or adolescents with stage IV Hodgkin's lymphoma or inadequate response to initial therapy after receiving ChIVPP and ABVD with EPIC, radiotherapy, high-dose melphalan, and APBSCT.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups based on disease status.

Group 1 (stage I disease): All patients with mixed cellularity and younger patients with any subtype are assigned to subgroup A. Older patients without mixed cellularity are assigned to subgroup A or B based on the decision of the physicians and patients/parents. Subgroup A: Patients receive 2 courses of the hybrid regimen. One course of the hybrid regimen comprises regimen ChIVPP followed by regimen ABVD. Regimen ChIVPP comprises vinblastine IV on days 1 and 8 and oral chlorambucil, oral procarbazine, and oral prednisolone (PRDL) daily on days 1-14. Regimen ABVD comprises doxorubicin IV over 6 hours, bleomycin IV over 15-30 minutes, vincristine IV, and dacarbazine IV over 15 minutes on days 1 and 14. Patients with relapsed disease receive etoposide IV over 1 hour on days 1-4, oral PRDL and ifosfamide IV over 1 hour on days 1-5, and cisplatin IV over 24 hours on day 10 (EPIC). Treatment with EPIC continues every 3 weeks for a total of 6 courses. Patients then undergo radiotherapy. Patients with poor response after radiotherapy receive consolidation with high-dose melphalan (L-PAM) IV over 30-90 minutes, followed at least 12 hours later by autologous peripheral blood stem cell transplantation (APBSCT) (if there is no bone marrow involvement at the time of relapse). Subgroup B: Patients not in subgroup A may either receive chemotherapy as outlined or radiotherapy depending on clinician and patient discussion. Patients with relapsed disease after radiotherapy receive 3 courses of the hybrid regimen. If relapse occurs outside the initial radiotherapy field, then further radiotherapy is administered.
Group 2 (stage II or III disease): Patients receive 3 courses of the hybrid regimen. Patients with relapsed disease receive 4 courses of EPIC. Patients with complete remission (CR) or good partial remission (GPR) after the fourth course of EPIC receive 2 additional courses of EPIC followed by radiotherapy. Patients without CR or GPR after the fourth course of EPIC undergo radiotherapy followed by L-PAM and APBSCT as in group 1, subgroup A.
Group 3 (stage IV or inadequate response to initial therapy): Patients receive 2 courses the hybrid regimen. Patients with CR or GPR after the second course of ABVD are assigned to subgroup C. Patients without CR or GPR after the second course of ABVD are assigned to subgroup D. Subgroup C: Patients receive 2 additional courses of the hybrid regimen. Patients with relapsed disease after the fourth course of ABVD receive 4 courses of EPIC followed by radiotherapy, L-PAM, and APBSCT as in group 1, subgroup A. Subgroup D: Patients receive 4 courses of EPIC followed by radiotherapy, L-PAM, and APBSCT as in group 1, subgroup A.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 260 patients (75 with stage I disease, 150 with stage II or III disease, and 35 with stage IV disease) will be accrued for this study within 5 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

260

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Det Forenede Kongerige
- England
  - Birmingham, England, Det Forenede Kongerige, B4 6NH
    - Birmingham Children's Hospital
  - Bristol, England, Det Forenede Kongerige, BS2 8BJ
    - Bristol Royal Hospital for Children
  - Cambridge, England, Det Forenede Kongerige, CB2 2QQ
    - Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  - Leeds, England, Det Forenede Kongerige, LS9 7TF
    - Leeds Cancer Centre at St. James's University Hospital
  - Leicester, England, Det Forenede Kongerige, LE1 5WW
    - Leicester Royal Infirmary
  - Liverpool, England, Det Forenede Kongerige, L12 2AP
    - Royal Liverpool Children's Hospital, Alder Hey
  - London, England, Det Forenede Kongerige, WC1N 3JH
    - Great Ormond Street Hospital for Children NHS Trust
  - London, England, Det Forenede Kongerige, EC1A 7BE
    - Saint Bartholomew's Hospital
  - London, England, Det Forenede Kongerige, WIT 3AA
    - Meyerstein Institute of Oncology at University College of London Hospitals
  - Manchester, England, Det Forenede Kongerige, M27 4HA
    - Central Manchester and Manchester Children's University Hospitals NHS Trust
  - Newcastle-Upon-Tyne, England, Det Forenede Kongerige, NE7 7DN
    - Newcastle Upon Tyne Hospitals NHS Trust
  - Nottingham, England, Det Forenede Kongerige, NG7 2UH
    - Queen's Medical Centre
  - Oxford, England, Det Forenede Kongerige, 0X3 9DU
    - Oxford Radcliffe Hospital
  - Sheffield, England, Det Forenede Kongerige, S10 2TH
    - Children's Hospital - Sheffield
  - Southampton, England, Det Forenede Kongerige, SO16 6YD
    - Southampton General Hospital
  - Sutton, England, Det Forenede Kongerige, SM2 5PT
    - Royal Marsden NHS Foundation Trust - Surrey
- Northern Ireland
  - Belfast, Northern Ireland, Det Forenede Kongerige, BT12 6BE
    - Royal Belfast Hospital for Sick Children
- Scotland
  - Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
    - Aberdeen Royal Infirmary
  - Edinburgh, Scotland, Det Forenede Kongerige, EH9 1LF
    - Royal Hospital for Sick Children
  - Glasgow, Scotland, Det Forenede Kongerige, G3 8SJ
    - Royal Hospital for Sick Children
Irland
- - Dublin, Irland, 12
    - Our Lady's Hospital for Sick Children

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically proven Hodgkin's lymphoma
- Stage I-IV
No posttransplantation Hodgkin's lymphoma
Mediastinal syndrome allowed

PATIENT CHARACTERISTICS:

Age:

Under 18 at diagnosis

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other previously treated malignancy
No DNA repair defect syndromes

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Cancer and Leukaemia Group

Efterforskere

Studiestol: Martin Hewitt, MD, BSc, FRCP, FRCPCH, Queen's Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2000

Datoer for studieregistrering

Først indsendt

11. oktober 2001

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2013

Sidst verificeret

1. december 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CCLG-HD-2000-02
CDR0000068901 (Registry Identifier: PDQ (Physician Data Query))
EU-20108

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