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

Hodgkins Disease Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00417014
Enrollment
358
Registered
2006-12-28
Start date
Unknown
Completion date
Unknown
Last updated
2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

RATIONALE: Drugs used in chemotherapy, such as chlorambucil, vinblastine, procarbazine, and prednisolone, 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) together with radiation therapy may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving combination chemotherapy and/or radiation therapy works in treating young patients with Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * Establish a uniform practice for the management of children with Hodgkin's lymphoma. * Document the long-term side effects of such management. * Establish whether or not children can be safely managed without staging laparotomy and splenectomy. * Establish whether or not chlorambucil, vinblastine, procarbazine hydrochloride, and prednisolone (CLVPP) is an effective alternative to mechlorethamine, vincristine, procarbazine hydrochloride, and prednisone (MOPP) chemotherapy. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment regimens according to disease stage and presence of bulky mediastinal disease. * Involved-field radiotherapy (for patients with stage IA \[nodal\] disease): Patients undergo involved-field radiotherapy 5 days a week for 4 weeks. * CLVPP chemotherapy (for patients with all other stages of disease AND no bulky mediastinal disease): Patients receive CLVPP chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV on days 1 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. * CLVPP chemotherapy and radiotherapy (for patients with all other stages of disease AND bulky mediastinal disease): Patients receive CLVPP chemotherapy as above. Patients then undergo radiotherapy to the mediastinum beginning 2 weeks after completing the last course of CLVPP chemotherapy. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 358 patients were accrued for this study.

Interventions

DRUGprocarbazine hydrochloride
DRUGvinblastine sulfate
RADIATIONradiation therapy
DRUGchlorambucil
DRUGprednisolone

Sponsors

Children's Cancer and Leukaemia Group
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Biopsy proven Hodgkin's lymphoma * Any stage allowed PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026