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Completed

NCT Number: NCT00002941

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carmustine

Drug

Other names: BCNU, NSC-409962

Cyclophosphamide

Drug

Other names: Cytoxan, NSC-26271

etoposide

Drug

Other names: VP-16, VePesid, NSC-141540

Mesna

Drug

Other names: Mesnex, NSC-113891

peripheral blood stem cell transplantation

Procedure

Primary outcomes

  1. Failure-free survival rate

    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.

Secondary outcomes

  1. Estimating parameters relevant to recovery of normal bone marrow function

  2. Predictive value of MRD assessment

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2002
Study completion
2007
First posted
Jan 27, 2003
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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