Radiation Therapy or Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416377
First received: December 27, 2006
Last updated: August 1, 2013
Last verified: December 2006
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This clinical trial is studying how well radiation therapy or combination chemotherapy work in treating young patients with Hodgkin's lymphoma.


Condition Intervention
Lymphoma
Biological: bleomycin sulfate
Drug: chlorambucil
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: prednisolone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: radiation therapy

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Hodgkin's Disease Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 353
Detailed Description:

OBJECTIVES:

  • Maintain the present satisfactory results of patients treated on protocol UKCCSG-HD-8201 in pediatric patients with stage I-III Hodgkin's lymphoma treated with radiotherapy or combination chemotherapy comprising chlorambucil, procarbazine hydrochloride, prednisolone, vinblastine followed by doxorubicin hydrochloride, bleomycin, vincristine, and dacarbazine.
  • Determine, by comparison with UKCCSG-HD-8201, if mediastinal irradiation can be safely omitted from the management of pediatric patients with Hodgkin's lymphoma and bulky mediastinal disease.
  • Determine if gallium scanning of the mediastinum after chemotherapy will identify patients with residual active mediastinal disease.
  • Improve disease control in patients with stage IV Hodgkin's lymphoma and slow responders by intensifying treatment to patients who fail to achieve complete remission after 4 courses of chlorambucil, vinblastine, procarbazine hydrochloride, and prednisone.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (I vs II-IV).

  • Stage I: Patients undergo involved-field radiotherapy.
  • Stage II-IV:

    • CHLVPP chemotherapy: Patients receive CHLVPP chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV on days 1-8. Treatment repeats every 28 days for 2 courses. Patients achieving complete resolution (CR) of measurable disease receive an additional 4 courses of CHLVPP. Patients with no response or progressive disease proceed to ABVD chemotherapy. Patients with shrinkage of measurable disease to < 50% original dimensions (GPR) receive 2 additional courses of CHLVPP. Patients achieving CR or GPR after completion of 2 additional courses of CHLVPP receive 4 more courses of CHLVPP. Patients achieving shrinkage of measurable disease to ≥ 50% of original dimension (PR) after 2 additional courses of CHLVPP OR patients not achieving CR after a total of 8 courses of CHLVPP proceed to ABVD chemotherapy.
    • ABVD chemotherapy: Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV over 4 hours and bleomycin IV, vincristine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
  • Mediastinal mass: Patients receive chemotherapy as per stages II-IV. Patients presenting with airway or superior vena cava obstruction may also undergo radiotherapy. Patients achieving CR after completion of chemotherapy receive no further treatment. Patients achieving GPR or PR after completion of chemotherapy undergo gallium scan and CT scan of thorax with or without biopsy at the investigator's discretion.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 353 patients were accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed childhood Hodgkin's lymphoma by lymph node biopsy

    • Any stage disease
    • Patients with bilateral upper cervical disease with no evidence of supraclavicular, thoracic inlet, or Waldeyers ring involvement are treated as having stage I disease

PATIENT CHARACTERISTICS:

  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416377

Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: Ann Barrett University of Glasgow
Investigator: Judith E. Kingston, MD St. Bartholomew's Hospital
Investigator: John Martin, MD Royal Liverpool Children's Hospital, Alder Hey
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00416377     History of Changes
Other Study ID Numbers: CCLG-HD-9201, CDR0000454741, EU-20586
Study First Received: December 27, 2006
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Chlorambucil
Dacarbazine
Prednisolone
Methylprednisolone Hemisuccinate
Procarbazine
Vinblastine
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014