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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398554
• Other study ID #: CDR0000514344
• Secondary ID: GPOH-HD-2002-PIL
• Status: Completed
• Phase: Phase 2
• Start date: June 2005
• Est. completion date: March 2013

Study information

• Verified date: March 2020
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• cyclophosphamide
1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
• doxorubicin hydrochloride
25mg/m²/day, 2 hours i.v.infusion on day 21
• etoposide
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
• prednisone
40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
• vinblastine sulfate
6 mg/m² i.v. bolus on day 1 and day 21
• vincristine sulfate
1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29

Radiation:
• radiation therapy
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)

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg
Germany	Charite University Medical Center of Berlin	Berlin
Germany	Medizinische Universitaetsklinik I at the University of Cologne	Cologne
Germany	Universitaets - Kinderklinik	Erlangen
Germany	Universitaetsfrauenklinik Frankfurt	Frankfurt
Germany	Universitaetsklinikum Halle	Halle
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaets - Kinderklinik	Leipzig
Germany	Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster	Muenster
Germany	Kinderklinik d. TU / Schwabing	Munich
Germany	Klinikum Oldenburg	Oldenburg
Switzerland	University Children's Hospital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Christine Mauz-Körholz	Martin-Luther-Universität Halle-Wittenberg

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Event-free survival		event-free survival at 5 years
Secondary	Overall survival		overall survival at 5 years