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LymphomaPhase 2NCT00398554

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

A Phase 2 study testing cyclophosphamide, doxorubicin hydrochloride and etoposide in people with Lymphoma, run by Christine Mauz-Körholz at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years, men only
Conditions the study is for
Lymphoma
What is being tested?
cyclophosphamide, doxorubicin hydrochloride and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
12 sitesin 2 countries
Study dates
Jun 2005to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • Men only
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Germany11 sites

  • Klinikum Augsburg

    Augsburg, D-86156

  • Charite University Medical Center of Berlin

    Berlin, D-13347

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Universitaets - Kinderklinik

    Erlangen, 91054

  • Universitaetsfrauenklinik Frankfurt

    Frankfurt, D-60596

  • Universitaetsklinikum Halle

    Halle, D-06097

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Universitaets - Kinderklinik

    Leipzig, D-04317

  • Kinderklinik d. TU / Schwabing

    Munich, 80804

  • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

    Münster, D-48149

  • Klinikum Oldenburg

    Oldenburg, D-26133

Other trials in Germany

Switzerland1 site

  • University Children's Hospital

    Zurich, CH-8032

Other trials in Switzerland

About this study

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

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.

Read the 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.

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
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cyclophosphamideDrug

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

  • doxorubicin hydrochlorideDrug

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

  • etoposideDrug

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

  • prednisoneDrug

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

  • vinblastine sulfateDrug

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

  • vincristine sulfateDrug

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

  • radiation therapyRadiation

    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)

Study groups in NCT00398554
Study groupRoleWhat they receive
VECOPAExperimentaldose and time intensified consoloditation chemotherapy cycle
Receives: Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vinblastine sulfate; Drug: vincristine sulfate; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)

  1. Event-free survival

    Measured: event-free survival at 5 years

  2. Overall survival

    Measured: overall survival at 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2006 (estimated)
  2. Study startJun 2005
  3. Primary completionOct 2012
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398554
Sponsor's protocol ID
CDR0000514344
Other IDs
GPOH-HD-2002-PILOT-VECOPA, EU-20652, EUDRACT-2004-005244-28
Status last verified
Mar 2020
First submitted
9 Nov 2006
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, doxorubicin hydrochloride and etoposide in people with Lymphoma, run by Christine Mauz-Körholz at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity at days 21 and 42 (+/- 2 days) of treatment (time frame: days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00398554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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