Back to resultsChemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
cyclophosphamide
etoposide
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease Refractory to standard therapy OR Relapsed following initial complete remission Measurable or evaluable disease Hepatic involvement must be histologically proven to be considered sole area of measurable disease If referred following successful induction therapy, measurable or evaluable disease not required No CNS disease PATIENT CHARACTERISTICS: Age: Physiologic 65 or under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the past 3 months No significant arrhythmia requiring medication Ejection fraction normal Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to Hodgkin's disease) Other: Not pregnant Negative pregnancy test No active serious medical condition that would preclude chemotherapy HIV negative No clinical evidence of AIDS PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004169
First Posted
December 10, 1999
Last Updated
June 21, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00004169
Brief Title
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease
Official Title
High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 1993 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease Refractory to standard therapy OR Relapsed following initial complete remission Measurable or evaluable disease Hepatic involvement must be histologically proven to be considered sole area of measurable disease If referred following successful induction therapy, measurable or evaluable disease not required No CNS disease
PATIENT CHARACTERISTICS: Age: Physiologic 65 or under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the past 3 months No significant arrhythmia requiring medication Ejection fraction normal Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to Hodgkin's disease) Other: Not pregnant Negative pregnancy test No active serious medical condition that would preclude chemotherapy HIV negative No clinical evidence of AIDS
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo I. Gordon, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hodgkin's Disease
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