Radiation Therapy or Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bleomycin sulfate
chlorambucil
dacarbazine
doxorubicin hydrochloride
prednisolone
procarbazine hydrochloride
vinblastine sulfate
vincristine sulfate
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00416377
First Posted
December 27, 2006
Last Updated
August 1, 2013
Sponsor
Children's Cancer and Leukaemia Group
1. Study Identification
Unique Protocol Identification Number
NCT00416377
Brief Title
Radiation Therapy or Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
Official Title
Hodgkin's Disease Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Children's Cancer and Leukaemia Group
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
353 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
chlorambucil
Intervention Type
Drug
Intervention Name(s)
dacarbazine
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
procarbazine hydrochloride
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Barrett
Organizational Affiliation
University of Glasgow
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Judith E. Kingston, MD
Organizational Affiliation
St. Bartholomew's Hospital
First Name & Middle Initial & Last Name & Degree
John Martin, MD
Organizational Affiliation
Royal Liverpool Children's Hospital, Alder Hey
12. IPD Sharing Statement
Learn more about this trial
Radiation Therapy or Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
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