Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
NCT ID: NCT00002521
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
INTERVENTIONAL
1993-02-28
2000-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cyclophosphamide, etoposide and cisplatin followed by bone marrow and/or peripheral stem cell transplantation in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) with syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell rescue in patients with relapsed or refractory, stage I-IV, intermediate- or high-grade non-Hodgkin's lymphoma.
* Determine the overall response rate and survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine the differences in the rates of engraftment, response, and survival of patients treated with bone marrow vs peripheral blood stem cell transplantation.
* Determine the response rate and survival of patients treated with consolidative radiotherapy after recovery from transplantation.
* Determine the toxic effects of 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 and 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diffuse mixed (small and large cell)
* Diffuse large cell
* Large cell immunoblastic
* Lymphoblastic
* Small noncleaved cell
* High-grade histology patients should first be considered for Protocol TUHSC-1520
* Must have chemosensitive disease, defined by 1 of the following conditions:
* Response to initial chemotherapy without obtaining complete response (CR)(refractory lymphoma)
* Relapse after chemotherapy-induced CR if tumor volume reduced by at least 25% for more than 1 month after completion of 1-3 courses of salvage chemotherapy (chemosensitive relapse)
* No chemoresistant disease, defined by the following conditions:
* Unresponsive or progressive disease during initial chemotherapy
* Relapse after chemotherapy-induced CR if tumor volume not reduced by at least 25% after completion of 1-3 courses salvage chemotherapy (chemoresistant relapse)
* No CNS involvement by lymphoma
* Syngeneic bone marrow transplantation offered to patients with consenting identical twin donor NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 15 to 60 (physically fit patients up to age 70 may be considered)
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST and ALT not persistently greater than 2 times normal
Renal:
* Creatinine less than 1.8 mg/dL
Cardiovascular:
* Cardiac ejection fraction at least 45%
Pulmonary:
* DLCO, FEV\_1, and FVC at least 50% predicted
* Resting pO\_2 at least 70 mm Hg
Other:
* HIV negative
* No other concurrent disease that would limit life expectancy
* No active infection
* No severe neurologic or emotional disorders
* Not pregnant
* Fertile patients must use effective contraception
* Adequate psychological support available
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Temple University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Temple Univeristy Health Systems
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenneth F. Mangan, MD, FACP
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fox Chase - Temple Cancer Center
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TUHSC-2161
Identifier Type: -
Identifier Source: secondary_id
NCI-V93-0248
Identifier Type: -
Identifier Source: secondary_id
CDR0000078282
Identifier Type: -
Identifier Source: org_study_id