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

Christine Mauz-Körholz

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Treatments

Drug: prednisone

Drug: cyclophosphamide

Drug: doxorubicin hydrochloride

Radiation: radiation therapy

Drug: vincristine sulfate

Drug: vinblastine sulfate

Drug: etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT00398554

CDR0000514344

EU-20652

EUDRACT-2004-005244-28

GPOH-HD-2002-PILOT-VECOPA

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

Male

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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