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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00002941
First received: November 1, 1999
Last updated: July 31, 2014
Last verified: July 2014

November 1, 1999
July 31, 2014
April 1998
November 2002   (final data collection date for primary outcome measure)
Failure-free survival rate [ Designated as safety issue: No ]
Estimate the failure-free survival rate and persistent grade 3 toxicity rate of PBSCT in recurrent HD and NHL patients and to perform interim safety monitoring based on these endpoints.
Not Provided
Complete list of historical versions of study NCT00002941 on ClinicalTrials.gov Archive Site
  • Estimating parameters relevant to recovery of normal bone marrow function [ Designated as safety issue: No ]
  • Predictive value of MRD assessment [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Drug: carmustine
    Other Names:
    • BCNU
    • NSC-409962
  • Drug: cyclophosphamide
    Other Names:
    • Cytoxan
    • NSC-26271
  • Drug: etoposide
    Other Names:
    • VP-16
    • VePesid
    • NSC-141540
  • Drug: mesna
    Other Names:
    • Mesnex
    • NSC-113891
  • Procedure: peripheral blood stem cell transplantation
Experimental: Reinduction Therapy
Two 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.
Interventions:
  • Drug: carmustine
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: mesna
  • Procedure: peripheral blood stem cell transplantation
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
March 2007
November 2002   (final data collection date for primary outcome measure)

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)

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00002941
A5962, COG-A5962, CCG-A5962, POG-A5962, CCG-5962, CDR0000065390
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Richard E. Harris, MD Children's Hospital Medical Center, Cincinnati
Children's Oncology Group
July 2014

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