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Combination Chemotherapy and/or Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: December 27, 2006   Last Updated: February 6, 2009   History of Changes
Sponsored by: Children's Cancer and Leukaemia Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00417014
  Purpose

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 Intervention
Lymphoma
Drug: chlorambucil
Drug: prednisolone
Drug: procarbazine hydrochloride
Drug: vinblastine
Radiation: radiation therapy

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Hodgkins Disease Study

Resource links provided by NLM:


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

Estimated Enrollment: 358
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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Biopsy proven Hodgkin's lymphoma

    • Any stage allowed

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417014

Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Study Chair: John Martin, MD Royal Liverpool Children's Hospital, Alder Hey
Investigator: A. Barratt, MD Royal Marsden - Surrey
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000454559, CCLG-HD-8201, EU-20585
Study First Received: December 27, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00417014     History of Changes
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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Hodgkin Lymphoma, Childhood
Methylprednisolone
Chlorambucil
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
Prednisolone acetate
Hormones
Hodgkin Disease
Lymphoma
Alkylating Agents
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hodgkin Lymphoma, Adult
Methylprednisolone acetate
Hodgkin's Disease
Antimitotic Agents
Glucocorticoids
Recurrence
Lymphatic Diseases
Tubulin Modulators
Prednisolone
Procarbazine
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Chlorambucil
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
Hormones
Therapeutic Uses
Lymphoma
Hodgkin Disease
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Glucocorticoids
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Prednisolone
Antineoplastic Agents, Alkylating
Procarbazine
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009