Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
NCT ID: NCT00002522
Last Updated: 2010-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1993-02-28
2002-02-28
Brief Summary
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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
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
70 Years
ALL
No
Sponsors
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Temple University
OTHER
Responsible Party
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Temple University Health Systems
Principal Investigators
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Kenneth F. Mangan, MD, FACP
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Fox Chase - Temple Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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TUHSC-2162
Identifier Type: -
Identifier Source: secondary_id
NCI-V93-0249
Identifier Type: -
Identifier Source: secondary_id
CDR0000078283
Identifier Type: -
Identifier Source: org_study_id