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

Christine Mauz-Körholz16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

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

Eligibility

Sex: MALEMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Klinikum Augsburg

Augsburg, Germany

Charite University Medical Center of Berlin

Berlin, Germany

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, Germany

Outcomes

Primary Outcomes

Toxicity at days 21 and 42 (+/- 2 days) of treatment

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 Outcomes

Event-free survival

Time frame: event-free survival at 5 years

Overall survival

Time frame: overall survival at 5 years

Data from ClinicalTrials.gov

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