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Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
cyclophosphamide
etoposide
autologous bone marrow transplantation
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
syngeneic bone marrow transplantation
radiation therapy
Sponsored by
Temple University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven stage I-IV Hodgkin's lymphoma Must have refractory or relapsed disease, defined by 1 of the following: Failure to achieve a complete remission (CR) after 4 courses of conventional-dose front-line chemotherapy Disease in second or greater remission Patients should be encouraged to undergo transplantation prior to a third salvage regimen Patients previously treated with multiple regimens considered on a case-by-case basis No chemoresistant disease, defined as active progression with tumor growth greater than 25% by volume during first-line chemotherapy Patients who respond to second-line chemotherapy may be eligible Stable residual masses after conventional-dose chemotherapy not considered treatment failures Active (refractory or relapsed) disease must be proven histologically or documented by gallium nitrate uptake Syngeneic marrow transplantation offered to patients with consenting identical twin donor No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 15 to 60 (selected patients up to age 70 may be eligible) Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times upper limit of normal Albumin greater than 3.0 g/dL Renal: Must meet 1 of the following criteria: Creatinine less than 1.8 mg/dL Creatinine clearance greater than 60 mL/min BUN less than 20 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO, FEV_1, and FVC greater than 50% of predicted OR Resting pO_2 greater than 70 mm Hg on room air Other: HIV negative No severe neurologic or emotional disorders No active infection No other disease that would limit life expectancy Not pregnant Fertile patients must use effective contraception Adequate psychosocial support required PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • Fox Chase - Temple Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 30, 2010
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT00002522
Brief Title
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Official Title
HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN'S DISEASE
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 1993 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Temple University

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with relapsed or refractory Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) followed by syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell (PBSC) rescue in patients with relapsed or refractory stage I-IV Hodgkin's lymphoma. Determine the overall response rate and survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine the differences in the rate of engraftment, response, and survival of patients treated with bone marrow vs PBSC transplantation. Determine the response rate and survival of patients treated with late consolidative radiotherapy after recovery from transplantation. Determine the toxicity of late consolidative radiotherapy after recovery from transplantation in these patients. OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells (PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor. Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow or are profoundly hypocellular undergo harvest of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC. Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4. Bone marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.) After recovery from transplantation, eligible patients receive consolidative radiotherapy to any site of prior bulk disease (greater than 5 cm) present at any time before transplantation and any site of disease present at the time of transplantation. Patients are followed at 3, 6, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A maximum of 30 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
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
syngeneic bone marrow transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage I-IV Hodgkin's lymphoma Must have refractory or relapsed disease, defined by 1 of the following: Failure to achieve a complete remission (CR) after 4 courses of conventional-dose front-line chemotherapy Disease in second or greater remission Patients should be encouraged to undergo transplantation prior to a third salvage regimen Patients previously treated with multiple regimens considered on a case-by-case basis No chemoresistant disease, defined as active progression with tumor growth greater than 25% by volume during first-line chemotherapy Patients who respond to second-line chemotherapy may be eligible Stable residual masses after conventional-dose chemotherapy not considered treatment failures Active (refractory or relapsed) disease must be proven histologically or documented by gallium nitrate uptake Syngeneic marrow transplantation offered to patients with consenting identical twin donor No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 15 to 60 (selected patients up to age 70 may be eligible) Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times upper limit of normal Albumin greater than 3.0 g/dL Renal: Must meet 1 of the following criteria: Creatinine less than 1.8 mg/dL Creatinine clearance greater than 60 mL/min BUN less than 20 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO, FEV_1, and FVC greater than 50% of predicted OR Resting pO_2 greater than 70 mm Hg on room air Other: HIV negative No severe neurologic or emotional disorders No active infection No other disease that would limit life expectancy Not pregnant Fertile patients must use effective contraception Adequate psychosocial support required PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth F. Mangan, MD, FACP
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase - Temple Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2442
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

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