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

NCT00416832 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000514355GPOH-HD-2002EU-20651
• Study Type: interventional
• Target: 648
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with radiation therapy works in treating young patients with Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

stage II childhood Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; stage IV childhood Hodgkin lymphoma; stage I childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (3)

• Safety and efficacy

• Reduction of gonadotoxicity

• Quality assurance

Interventions

cyclophosphamide DRUG

dacarbazine DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

prednisone DRUG

procarbazine hydrochloride DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Diagnosis of classic Hodgkin's lymphoma (HL) * Intermediate or advanced disease, including the following stages: * Stage I * Stage IIA, IIB, IIE, or IIBE * Stage IIIA or IIIBE * Stage IV PATIENT CHARACTERISTICS: * No other concurrent malignancies * No severe concurrent diseases (e.g., immune deficiency syndrome) PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * Pre-phase therapy for large mediastinal tumor allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Christine Mauz-Körholz: lead

MeSH Terms

Conditions

Lymphoma

Interventions

Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Prednisone; Procarbazine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Dieter Koerholz, MD

  Martin-Luther-Universität Halle-Wittenberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Christine Mauz-Körholz

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: November 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: March 26, 2020

Record last verified: 2020-03