Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have recurrent or refractory Hodgkin’s lymphoma or non-Hodgkin’s lymphoma.

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells.

Official Title

A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin’s and Non-Hodgkin’s Lymphoma

Conditions

Lymphoma

Study Type

Interventional

Study Design

Treatment

Further Details

OBJECTIVES:

  • Estimate the failure-free survival rate in a cohort of relapsed Hodgkin’s lymphoma and non-Hodgkin’s lymphoma patients after retrieval therapy which includes peripheral blood stem cell transplantation (PBSCT) in patients who achieve a complete remission or partial remission.
  • Estimate the post complete/partial remission failure-free survival rate in these patients.
  • Characterize the time to recovery of normal bone marrow function after transplantation in these patients.

Study Start

June 2002

Eligibility & Criteria

  • Ages Eligible for Study: 1 Year – 21 Years
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • DISEASE CHARACTERISTICS:
    • Histologically confirmed non-Hodgkin’s lymphoma in first relapse or refractory after primary induction therapy
    • Histologically confirmed Hodgkin’s lymphoma in first relapse after chemotherapy with more than one nodal region involved at relapse or refractory after primary induction therapy (i.e., failed to achieve remission at the conclusion of standard induction chemotherapy):
      • No prior radiotherapy only for low stage nodal disease
      • No greater than 4 courses of standard chemotherapy for low stage nodal disease
    • CSF or bone marrow involvement at time of study entry is allowed
  • PATIENT CHARACTERISTICS:
    • Age: 1 to 21 (at initial diagnosis)
    • Hepatic:
      • SGOT or SGPT less than 2.5 times normal
      • Bilirubin no greater than 1.5 mg/dL
    • Renal:
      • Creatinine less than 1.5 mg/dL
      • Glomerular filtration rate greater than 60 mL/min as measured by radionuclide scan or 24 hour urine collection for creatinine clearance
    • Cardiovascular:
      • Shortening fraction of at least 28% by echocardiogram
      • Ejection fraction of at least 40% by radionuclide angiogram echocardiogram
    • Pulmonary:
      • Total lung capacity (TLC) at least 50% OR
      • Vital capacity (VC) at least 65% of normal
      • DLCO at least 55% of normal
      • For children who are uncooperative to pulmonary function testing, no dyspnea at rest or with mild exercise, and a pulse oximetry of at least 95%
    • Other: HIV negative

Total Enrolment

30

Contact Details

  • Children’s Hospital at Westmead, Westmead, New South Wales, 2145, Australia
  • Sydney Children’s Hospital, Randwick, New South Wales, 2031, Australia
  • Royal Children’s Hospital, Brisbane, Queensland, 4029, Australia
  • Women’s and Children’s Hospital, North Adelaide, South Australia, 5006, Australia
  • Royal Children’s Hospital, Parkville, Victoria, 3052, Australia
  • Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia

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