Completed

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

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What is being tested

carmustine

+ cyclophosphamide

+ etoposide

DrugProcedure
Who is being recruted

DNA Virus Infections+22

+ Hemic and Lymphatic Diseases

+ Herpesviridae Infections

From 1 to 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1998
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: August 1, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00002941
Principal SponsorChildren's Oncology Group
Last updated: August 1, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellEpstein-Barr Virus InfectionsDisease AttributesBurkitt LymphomaLymphomaRecurrenceLymphoma, Large B-Cell, DiffuseDendritic Cell Sarcoma, Interdigitating

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) 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 235 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

University of South Alabama Medical Center

Mobile, United States

Phoenix Children's Hospital

Phoenix, United States

Arizona Cancer Center

Tucson, United States
Completed235 Study Centers