Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma

NCT00398554 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000514344GPOH-HD-2002-PILOT-VECOPAEU-20652EUDRACT-2004-005244-28
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 12

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. Giving combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well combination chemotherapy works in treating young male 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; childhood lymphocyte depletion Hodgkin lymphoma; childhood mixed cellularity Hodgkin lymphoma; childhood nodular sclerosis Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Toxicity at days 21 and 42 (+/- 2 days) of treatment

  number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery

  days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle

Secondary Outcomes (2)

• Event-free survival

  event-free survival at 5 years

• Overall survival

  overall survival at 5 years

Study Arms (1)

VECOPA

EXPERIMENTAL

dose and time intensified consoloditation chemotherapy cycle

Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vinblastine sulfate; Drug: vincristine sulfate; Radiation: radiation therapy

Interventions

cyclophosphamide DRUG

1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21

VECOPA

doxorubicin hydrochloride DRUG

25mg/m²/day, 2 hours i.v.infusion on day 21

VECOPA

etoposide DRUG

150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3

VECOPA

prednisone DRUG

40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34

VECOPA

vinblastine sulfate DRUG

6 mg/m² i.v. bolus on day 1 and day 21

VECOPA

vincristine sulfate DRUG

1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29

VECOPA

radiation therapy RADIATION

involved field irradiation, single daily fractions 1,5 Gy to max. 1,8 Gy standard dose 20 Gy, max dose 30 Gy (boost irradiation if required)

VECOPA

Eligibility Criteria

• Age: Up to 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of classic Hodgkin's lymphoma (HL) * Intermediate or advanced disease (stage I\[E\]-IV) * No lymphocyte-predominant HL * Previously untreated disease PATIENT CHARACTERISTICS: * Male * No known hypersensitivity or contraindication to study drugs * No other concurrent malignancies * No severe concurrent diseases (e.g., immune deficiency syndrome) * No known HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or radiotherapy * More than 30 days since prior and no other concurrent investigational drugs * More than 30 days since prior and no concurrent participation in another clinical trial

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
• Martin-Luther-Universität Halle-Wittenberg: collaborator

Study Sites (12)

Klinikum Augsburg

Augsburg, D-86156, Germany

Location

Charite University Medical Center of Berlin

Berlin, D-13347, Germany

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Universitaets - Kinderklinik

Erlangen, 91054, Germany

Location

Universitaetsfrauenklinik Frankfurt

Frankfurt, D-60596, Germany

Location

Universitaetsklinikum Halle

Halle, D-06097, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Universitaets - Kinderklinik

Leipzig, D-04317, Germany

Location

Kinderklinik d. TU / Schwabing

Munich, 80804, Germany

Location

Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

Münster, D-48149, Germany

Location

Klinikum Oldenburg

Oldenburg, D-26133, Germany

Location

University Children's Hospital

Zurich, CH-8032, Switzerland

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Cyclophosphamide; Doxorubicin; Etoposide; Prednisone; Vinblastine; 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; 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; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; 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
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Secretary of the EuroNet-PHL group

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: June 1, 2005
• Primary Completion: October 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

DE (11); CH (1)