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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


Phase 2
N/A
18 Years
Open (Enrolling)
Male
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery

Outcome Time Frame:

days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle

Safety Issue:

Yes

Principal Investigator

Dieter Koerholz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Martin-Luther-Universit├Ąt Halle-Wittenberg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CDR0000514344

NCT ID:

NCT00398554

Start Date:

June 2005

Completion Date:

March 2013

Related Keywords:

  • Lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • childhood lymphocyte depletion Hodgkin lymphoma
  • childhood mixed cellularity Hodgkin lymphoma
  • childhood nodular sclerosis Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

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