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

• Sponsor: Children's Cancer and Leukaemia Group (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00417014
• Collaborator: (none)
• Enrollment: 358

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: chlorambucil; Drug: prednisolone; Drug: procarbazine hydrochloride; Drug: vinblastine sulfate; Radiation: radiation therapy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 358 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hodgkins Disease Study

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Biopsy proven Hodgkin's lymphoma

• Any stage allowed

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's Cancer and Leukaemia Group

Investigators

• Study Chair: John Martin, MD, Royal Liverpool Children's Hospital, Alder Hey
• : A. Barratt, MD, Royal Marsden NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00417014
• Other Study ID Numbers: CCLG-HD-8201; CDR0000454559; EU-20585
• First Posted: Dec 28, 2006
• Last Update Posted: Aug 2, 2013
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: 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: Lymphoma; Prednisolone; Vinblastine; Procarbazine; Chlorambucil

Study Results

No Results Posted as of Aug 2, 2013