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Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
rituximab
sargramostim
carmustine
cisplatin
cyclophosphamide
dexamethasone
etoposide
gemcitabine hydrochloride
melphalan
paclitaxel
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I grade 3 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, stage I mantle cell lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade B-cell non-Hodgkin's lymphoma that meets one of the following criteria: - Relapsed or progressed following at least 1 course of standard therapy - Developed from a low grade lymphoma regardless of remission status - In first complete response with 3 or more of the following pretreatment criteria met at the time of original diagnosis: Stage III/IV disease Two or more extranodal sites of disease Lactate dehydrogenase greater than 1.2 times normal Performance status 2-4 (at time of diagnosis) Dimension of the largest tumor at least 10 cm No myelodysplasia 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: 18 to 75 Performance status: See Disease Characteristics ECOG 0-2 (ECOG 3-4 acceptable if based solely on pain) Life expectancy: Not specified Hematopoietic: CD34 cells at least 1,000/g Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: No evidence for clinically significant functional impairment Left ventricular ejection fraction at least 45% Patients with lower ejection fractions may be included if a formal cardiological evaluation reveals no evidence for clinically significant functional impairment Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted If unable to complete pulmonary function tests due to bone pain or fracture, must have a high resolution CT scan of the chest and acceptable blood arterial gases defined as PO2 greater than 70 Other: HIV negative No active infection that is unresponsive to intravenous antibiotics Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: See Disease Characteristics

Sites / Locations

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 31, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland Greenebaum Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00003397
Brief Title
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Official Title
Autologous Stem Cell Transplantation for Poor Prognosis, Relapsed, or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab (IDEC C2B8, Rituximab, Rituxan) and Consolidative Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland Greenebaum Cancer Center

4. Oversight

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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: I. Evaluate the 1 and 2 year event free survival of patients with poor prognosis, relapsed or refractory intermediate or high grade B-cell non-Hodgkin's lymphoma who receive high dose carmustine and melphalan plus gemcitabine followed by rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) plus sargramostim and consolidation chemotherapy with alternating dexamethasone/cyclophosphamide/ etoposide/cisplatin plus gemcitabine and paclitaxel/cisplatin and compare these figures to a historical control population. II. Evaluate the ability of posttransplant rituximab therapy in combination with sargramostim (GM-CSF) to control and further treat residual lymphoma remaining after high dose therapy in these patients. III. Evaluate quality of life parameters and assess the risk of secondary malignancies following this treatment regimen in these patients. OUTLINE: Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again approximately 6 hours after carmustine IV over 2 hours on day -2. On day -1, patients receive melphalan IV over 20 minutes followed 24 hours later (day 0) with peripheral blood stem cells transplantation. Patients then receive sargramostim (GM-CSF) subcutaneously beginning on day 4 until granulocyte count is greater than 1,000/mm3 for 2 consecutive days. At weeks 5-8 posttransplant, patients receive rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) IV over 3-4 hours weekly. Prior to rituximab treatment at week 4 posttransplant, patients receive sargramostim (GM-CSF) subcutaneously 3 times a week continuing through rituximab therapy. At approximately 3 and 9 months posttransplant, patients receive dexamethasone orally every day for days 1-4, and cyclophosphamide, etoposide, and cisplatin by continuous infusion for 4 days (days 1-4), and gemcitabine IV over 100 minutes on days 1 and 5. At approximately 6 and 12 months posttransplant, patients receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3. Patients are followed at least every 6 weeks to 3 months until death. PROJECTED ACCRUAL: An estimated 25 patients per year will be accrued into 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 grade 3 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult Burkitt lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, stage I mantle cell lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult Burkitt lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade B-cell non-Hodgkin's lymphoma that meets one of the following criteria: - Relapsed or progressed following at least 1 course of standard therapy - Developed from a low grade lymphoma regardless of remission status - In first complete response with 3 or more of the following pretreatment criteria met at the time of original diagnosis: Stage III/IV disease Two or more extranodal sites of disease Lactate dehydrogenase greater than 1.2 times normal Performance status 2-4 (at time of diagnosis) Dimension of the largest tumor at least 10 cm No myelodysplasia 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: 18 to 75 Performance status: See Disease Characteristics ECOG 0-2 (ECOG 3-4 acceptable if based solely on pain) Life expectancy: Not specified Hematopoietic: CD34 cells at least 1,000/g Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: No evidence for clinically significant functional impairment Left ventricular ejection fraction at least 45% Patients with lower ejection fractions may be included if a formal cardiological evaluation reveals no evidence for clinically significant functional impairment Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted If unable to complete pulmonary function tests due to bone pain or fracture, must have a high resolution CT scan of the chest and acceptable blood arterial gases defined as PO2 greater than 70 Other: HIV negative No active infection that is unresponsive to intravenous antibiotics Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron P. Rapoport, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

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