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Surgery Alone, Surgery With Cyclophosphamide, Vinblastine, and Prednisolone (CVP), or CVP Alone in Treating Young Patients With Stage IA or Stage IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma

This study is currently recruiting participants.
Verified March 2010 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01088750
First received: March 16, 2010
Last updated: November 2, 2010
Last verified: March 2010
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.

PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.


Condition Intervention Phase
Lymphoma
 Drug: cyclophosphamide
Drug: prednisolone
Drug: vinblastine sulfate
Other: watchful waiting
Procedure: therapeutic conventional surgery
 Phase 4

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Complications of surgery [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2009
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone.

Secondary

  • Determine if this regimen results in a decrease in overall survival rates, in significant upstaging at relapse, or increased rates of histological transformation in these patients.

OUTLINE:

  • Group 1 (patients with stage IA disease only): Patients undergo surgical resection of the involved lymph nodes. Patients who achieve complete resection then enter follow-up (watch and wait); patients who do not achieve complete resection enters group 2 treatment.
  • Group 2 (patients with stage IIA disease or incompletely resected stage IA disease): Patients receive cyclophosphamide, vinblastine, and prednisolone for 3 courses. Patients with good response enter follow-up (watch and wait). Patients without a good response are taken off protocol.

After completion of study treatment, patients are followed-up periodically.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma

    • Stage IA or IIA disease

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088750

Locations
Germany
Universitaetsklinikum Halle Recruiting
Halle, Germany, D-06120
Contact: Contact Person     49-345-557-2387     dieter.koerholz@medizin.uni-halle.de    
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Dieter Koerholz, MD Martin-Luther-Universität Halle-Wittenberg
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT01088750     History of Changes
Other Study ID Numbers: CDR0000667369, EURONET-PHL-LP1, EUDRACT-2007-004092-19, EU-21011
Study First Received: March 16, 2010
Last Updated: November 2, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood nodular lymphocyte predominant Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisolone
Methylprednisolone Hemisuccinate
Vinblastine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
 Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on June 18, 2013