Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: July 23, 2010
Last verified: April 2003

November 1, 1999
July 23, 2010
June 2002
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Complete list of historical versions of study NCT00002941 on Archive Site
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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma
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

RATIONALE: 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.

PURPOSE: 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.


  • 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.

OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given.

The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course, consisting of the following:

  • Carmustine IV over 3 hours on days -8, -7, and -6
  • Etoposide continuous IV over days -8, -7, and -6
  • Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2
  • Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine.

PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.

Phase 2
Primary Purpose: Treatment
  • Drug: carmustine
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: mesna
  • Procedure: peripheral blood stem cell transplantation
Not Provided
Harris RE, Termuhlen AM, Smith LM, Lynch J, Henry MM, Perkins SL, Gross TG, Warkentin P, Vlachos A, Harrison L, Cairo MS. Autologous Peripheral Blood Stem Cell Transplantation in Children with Refractory or Relapsed Lymphoma: Results of Children's Oncology Group Study A5962. Biol Blood Marrow Transplant. 2010 Jul 14; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
Not Provided


  • 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



  • 1 to 21 (at initial diagnosis)

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • SGOT or SGPT less than 2.5 times normal
  • Bilirubin no greater than 1.5 mg/dL


  • 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


  • Shortening fraction of at least 28% by echocardiogram
  • Ejection fraction of at least 40% by radionuclide angiogram echocardiogram


  • 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%


  • HIV negative


Biologic therapy:

  • Not specified


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • Not specified
1 Year to 21 Years
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
CDR0000065390, COG-A5962, CCG-A5962, POG-A5962, CCG-5962
Not Provided
Not Provided
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Richard E. Harris, MD Children's Hospital Medical Center, Cincinnati
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP