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High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and peripheral stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease.
OBJECTIVES: I. Determine the toxicity and response to high dose chemotherapy and peripheral blood stem cell support in patients with recurrent or refractory Hodgkin's disease. II. Determine the maximum tolerated dose of etoposide when combined with carboplatin and cyclophosphamide in these patients. OUTLINE: This is a dose escalation study of etoposide. Patients undergo total nodal radiotherapy twice a day on days -35 to -31, -28 to -24, and then radiotherapy boost once a day on days -21 to -17. Patients then receive etoposide IV continuously and carboplatin IV continuously on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Autologous peripheral blood stem cells are infused on day 0. Patients who have received prior extensive radiation (at least 2000 cGy to any site) only receive chemotherapy and peripheral blood stem cell infusion. Cohorts of 4-8 patients receive escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 4 or 2 of 8 patients experience dose limiting toxicity. Patients are followed every 1-3 months for 2 years, then every 3 months until death. PROJECTED ACCRUAL: At least 4 patients will be accrued for this study.
Age
0 - 65 years
Sex
ALL
Healthy Volunteers
No
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Start Date
November 1, 1993
Primary Completion Date
January 1, 2007
Completion Date
January 1, 2007
Last Updated
July 2, 2012
carboplatin
DRUG
cyclophosphamide
DRUG
etoposide
DRUG
peripheral blood stem cell transplantation
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
Northwestern University
Collaborators
NCT06337318
NCT06263491
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05139017