Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
vinblastine sulfate
vincristine sulfate
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Klinikum Augsburg
- Charite University Medical Center of Berlin
- Medizinische Universitaetsklinik I at the University of Cologne
- Universitaets - Kinderklinik
- Universitaetsfrauenklinik Frankfurt
- Universitaetsklinikum Halle
- Medizinische Hochschule Hannover
- Universitaets - Kinderklinik
- Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
- Kinderklinik d. TU / Schwabing
- Klinikum Oldenburg
- University Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VECOPA
Arm Description
dose and time intensified consoloditation chemotherapy cycle
Outcomes
Primary Outcome Measures
Toxicity at days 21 and 42 (+/- 2 days) of treatment
number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery
Secondary Outcome Measures
Event-free survival
Overall survival
Full Information
NCT ID
NCT00398554
First Posted
November 9, 2006
Last Updated
March 24, 2020
Sponsor
Christine Mauz-Körholz
Collaborators
Martin-Luther-Universität Halle-Wittenberg
1. Study Identification
Unique Protocol Identification Number
NCT00398554
Brief Title
Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
Official Title
Pilot Study for Therapy Optimising for Hodgkin's Lymphoma in Childhood and Adolescence; Optimising Therapy for Boys With Hodgkin's Lymphoma in Intermediate and Advanced Stages. Safety and Efficacy Study for Drug Combination VECOPA
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christine Mauz-Körholz
Collaborators
Martin-Luther-Universität Halle-Wittenberg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
OBJECTIVES:
Determine the safety and efficacy of combination chemotherapy comprising vincristine, etoposide, cyclophosphamide, vinblastine, prednisone, and doxorubicin hydrochloride (VECOPA) in pediatric male patients with previously untreated stage II-IV classic Hodgkin's lymphoma.
Compare the effects of VECOPA vs cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone (COPP) in these patients.
OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (IA/B[E], IIA[E], IIB, or IIIA vs IIB[E], IIIA/B[E], IIIB, or IVA/B).
Stratum 1 (stages IA/B[E], IIA[E], IIB, or IIIA): Patients receive oral prednisone on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin hydrochloride IV over 4 hours on days 1 and 15, and etoposide IV over 2 hours on days 2-6 (OEPA). Treatment repeats every 4 weeks for 2 courses. Beginning at week 9, patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34, etoposide IV over 2 hours on days 1-3, doxorubicin hydrochloride IV over 2 hours on day 21, vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21, and vincristine IV on days 8 and 29. Patients then undergo radiotherapy.
Stratum 2 (stages IIB[E], IIIA/B[E], IIIB, or IVA/B): Patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of VECOPA (6-week courses). Patients then undergo radiotherapy.
After completion of study treatment, patients are followed periodically for at least 6 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VECOPA
Arm Type
Experimental
Arm Description
dose and time intensified consoloditation chemotherapy cycle
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
25mg/m²/day, 2 hours i.v.infusion on day 21
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Intervention Description
6 mg/m² i.v. bolus on day 1 and day 21
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Description
1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Toxicity at days 21 and 42 (+/- 2 days) of treatment
Description
number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery
Time Frame
days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle
Secondary Outcome Measure Information:
Title
Event-free survival
Time Frame
event-free survival at 5 years
Title
Overall survival
Time Frame
overall survival at 5 years
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Koerholz, MD
Organizational Affiliation
Martin-Luther-Universität Halle-Wittenberg
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
D-86156
Country
Germany
Facility Name
Charite University Medical Center of Berlin
City
Berlin
ZIP/Postal Code
D-13347
Country
Germany
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Universitaets - Kinderklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsfrauenklinik Frankfurt
City
Frankfurt
ZIP/Postal Code
D-60596
Country
Germany
Facility Name
Universitaetsklinikum Halle
City
Halle
ZIP/Postal Code
D-06097
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Universitaets - Kinderklinik
City
Leipzig
ZIP/Postal Code
D-04317
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Kinderklinik d. TU / Schwabing
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
D-26133
Country
Germany
Facility Name
University Children's Hospital
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
12. IPD Sharing Statement
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Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
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