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

Sponsor

Christine Mauz-Körholz (Other)

Overall Status

Completed

CT.gov ID

NCT00398554

Collaborator

Martin-Luther-Universität Halle-Wittenberg (Other)

Enrollment

Locations

Arm

Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate Radiation: radiation therapy	Phase 2

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VECOPA dose and time intensified consoloditation chemotherapy cycle	Drug: cyclophosphamide 1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21 Drug: doxorubicin hydrochloride 25mg/m²/day, 2 hours i.v.infusion on day 21 Drug: etoposide 150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3 Drug: prednisone 40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34 Drug: vinblastine sulfate 6 mg/m² i.v. bolus on day 1 and day 21 Drug: 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)

Arm

Intervention/Treatment

Experimental: VECOPA

dose and time intensified consoloditation chemotherapy cycle

Drug: cyclophosphamide

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

Drug: doxorubicin hydrochloride

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

Drug: etoposide

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

Drug: prednisone

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

Drug: vinblastine sulfate

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

Drug: 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)

Outcome Measures

Primary Outcome Measures

Toxicity at days 21 and 42 (+/- 2 days) of treatment [days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle]
number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery

Secondary Outcome Measures

Event-free survival [event-free survival at 5 years]
Overall survival [overall survival at 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Klinikum Augsburg	Augsburg	Germany	D-86156
2	Charite University Medical Center of Berlin	Berlin	Germany	D-13347
3	Medizinische Universitaetsklinik I at the University of Cologne	Cologne	Germany	D-50924
4	Universitaets - Kinderklinik	Erlangen	Germany	91054
5	Universitaetsfrauenklinik Frankfurt	Frankfurt	Germany	D-60596
6	Universitaetsklinikum Halle	Halle	Germany	D-06097
7	Medizinische Hochschule Hannover	Hannover	Germany	D-30625
8	Universitaets - Kinderklinik	Leipzig	Germany	D-04317
9	Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster	Muenster	Germany	D-48149
10	Kinderklinik d. TU / Schwabing	Munich	Germany	80804
11	Klinikum Oldenburg	Oldenburg	Germany	D-26133
12	University Children's Hospital	Zurich	Switzerland	CH-8032