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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma

C

Christine Mauz-Körholz

Status and phase

Completed
Phase 2

Conditions

Lymphoma

Treatments

Drug: prednisone
Radiation: radiation therapy
Drug: etoposide
Drug: vincristine sulfate
Drug: cyclophosphamide
Drug: procarbazine hydrochloride
Drug: doxorubicin hydrochloride
Drug: dacarbazine

Study type

Interventional

Funder types

Other

Identifiers

NCT00416832
EU-20651
GPOH-HD-2002
CDR0000514355

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. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with radiation therapy works in treating young patients with Hodgkin's lymphoma.

Full description

OBJECTIVES:

  • Determine the safety and efficacy of intensified etoposide administered as a part of OEPA combination chemotherapy (vincristine, etoposide, prednisone, and doxorubicin hydrochloride) in pediatric male patients with intermediate or advanced Hodgkin's lymphoma (HL).
  • Determine the safety and efficacy of COPDIC combination chemotherapy (cyclophosphamide, vincristine, prednisone, and dacarbazine) or COPP combination chemotherapy (cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone) in reducing gonadotoxicity in male or female patients.
  • Assess quality assurance of these regimens in pediatric female patients with intermediate or advanced HL.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (I or IIA vs IIB, IIE, or IIIA vs IIBE, IIIBE, or IV).

  • Stratum 1 (stages I or IIA): Male patients receive vincristine IV on days 1, 8, and 15, etoposide IV over 2 hours on days 3-7, oral prednisone on days 1-15, and doxorubicin hydrochloride IV over 4 hours on days 1 and 15 (OEPA). Female patients receive vincristine, prednisone, and doxorubicin hydrochloride as in male patients and oral procarbazine hydrochloride on days 1-15 (OPPA). Both regimens repeat every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who do not achieve complete remission undergo involved-field radiotherapy beginning 3 weeks after completion of chemotherapy.
  • Stratum 2 (stages IIB, IIE, or IIIA): Male patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of COPDIC comprising oral prednisone on days 1-15, dacarbazine IV over 30 minutes on days 1-3, and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8. Female patients receive 2 courses of OPPA as in stratum 1 followed by COPP comprising oral prednisone and 2 courses of oral procarbazine hydrochloride on days 1-15 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8. Both regimens repeat every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after completion of chemotherapy, all patients undergo involved-field radiotherapy.
  • Stratum 3 (stages IIBE, IIIBE, or IV): Male patients receive 2 courses of OEPA as in stratum 1 followed by 4 courses of COPDIC as in stratum 2. Female patients receive 2 courses of OPPA as in stratum 1 followed by 4 courses of COPP as in stratum 2. Beginning 3 weeks after completion of chemotherapy, all patients undergo involved-field radiotherapy.

PROJECTED ACCRUAL: A total of 648 patients will be accrued for this study.

Enrollment

648 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of classic Hodgkin's lymphoma (HL)

    • Intermediate or advanced disease, including the following stages:

      • Stage I
      • Stage IIA, IIB, IIE, or IIBE
      • Stage IIIA or IIIBE
      • Stage IV

PATIENT CHARACTERISTICS:

  • No other concurrent malignancies
  • No severe concurrent diseases (e.g., immune deficiency syndrome)

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  • Pre-phase therapy for large mediastinal tumor allowed

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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