LymphomaPhase 2NCT00002552
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
A Phase 2 study testing filgrastim, sargramostim and carmustine in people with Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow doctors to give higher doses of chemotherapy and kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- filgrastim, sargramostim and carmustine
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1993to Oct 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL), and multiple myeloma (MM) meeting the following requirements: Refractory to or at high risk following prior therapy Responded with at least a partial response to last cytoreductive regimen No bulky disease (individual tumor diameter larger than 5 cm) Eligible HD: CNS involvement at original presentation and currently in complete response (CR) Relapsed within 1 year following completion of front-line MOPP or ABVD Relapsed at any time following front-line MOPP/ABVD or other hybrid Eligible NHL: Any grade lymphoma with CNS involvement at original presentation and currently in CR High-grade lymphomas (International Working Formulation H-J) with marrow involvement at original presentation and currently in CR, EXCEPT: Immunoblastic lymphoma and large cell (IWF G and H) with bone marrow involvement with small cleaved cell at original presentation High-/intermediate-grade lymphomas (IWF D-J) in relapse after adequate front-line therapy High-/intermediate-grade lymphomas (IWF D-J) that failed to achieve CR with adequate front-line therapy Low-grade lymphomas (IWF A-C) with B symptoms at original presentation and relapse after front-line therapy Low-grade lymphomas (IWF A-C) in relapse within 1 year following last chemotherapy Low-grade lymphomas (IWF A-C) with documented histologic conversion Eligible MM: Diagnosis based on either presence of both Group I diagnostic criteria OR One Group I criterion and all Group II criteria Group I diagnostic criteria: Plasma cells and/or myeloma cells greater than 10% in bone marrow Biopsy-proven plasmacytoma in bone or soft tissue Group II diagnostic criteria: Monoclonal serum protein spike Urinary myeloma protein Osteolytic lesions on radiologic examination Generalized osteoporosis suffices if plasma cells in marrow exceed 30% Myeloma cells in at least 2 peripheral blood smears Stage II/III disease documented sometime during clinical course Stage III defined by presence of at least 1 of the following: Hemoglobin less than 8.5 g/dl Serum calcium greater than 12 mg/dl Advanced lytic bone lesions High M-component production rates: IgG greater than 7 g/dl IgA greater than 5 g/dl Urinary light chain greater than 4 g/24 hours Stage II disease defined by absence of Stage III characteristics but presence of at least 1 of the following: Hb less than 10 g/dl More than 1 osteolytic lesion, none advanced IgG greater than 5 g/dl IgA greater than 3 g/dl Bone marrow donor available for lymphoma patients with marrow involvement Perfosfamide-purged autologous transplant allowed in patients with no matched sibling donor if: Marrow involvement is limited (less than 30% tumor cells on smears and in bilateral iliac crest biopsies) AND Age is under 60 Donor requirements: Excellent physical condition by history, lab studies, PE No physiologic, psychologic, or medical inability to tolerate the procedure No increased anesthetic risk No HIV infection Priority of multiple donors (in order given): ABO compatible Age over 18 Same sex as recipient 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: 70 and under Performance status: 0-2 Life expectancy: No severe limitation due to nonmalignant disease Hematopoietic: Not specified Hepatic: No severe hepatic disease Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3 times normal Renal: No severe renal disease Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic cardiac disease LVEF at least 50% Pulmonary: No severe pulmonary disease FEV1 and FVC at least 75% of normal Other: No history of severe cystitis with cyclophosphamide No HIV infection No severe personality disorder or severe mental illness No other condition that would markedly increase the morbidity and mortality of transplantation (e.g., substance abuse) Patients with borderline parameters of organ function, performance status, or mental status are entered at the discretion of the transplant team
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving a bone marrow transplant together with chemotherapy and to see how well it works in treating patients with refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.
Read the detailed description
OBJECTIVES: I. Assess the toxicities, response rate, and duration of response associated with high-dose cyclophosphamide, etoposide, carmustine or high-dose cyclophosphamide and total-body irradiation followed by autologous, allogeneic, or syngeneic bone marrow transplant in patients with refractory or high-risk non-Hodgkin's lymphoma, Hodgkin's disease, or multiple myeloma. II. Evaluate any prognostic factors.
OUTLINE: Patients with prior radiotherapy (greater than 2,000 cGy) receive cyclophosphamide IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by carmustine IV over 2 hours on day -3. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Patients with or without prior radiotherapy (less than 2,000 cGy) receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body irradiation on days -4 through -1. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Prior to autologous bone marrow transplantation and following myeloablative chemotherapy, patients undergo mobilization consisting of cytarabine subcutaneously every 12 hours for 6 doses. Approximately 24 hours later, patients receive sargramostim (GM-CSF) subcutaneously. Peripheral blood stem cells are collected every 1-3 days beginning when blood counts recover and continuing until sufficient number of cells are reached.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
- Being tested
- filgrastim, sargramostim, carmustine, cyclophosphamide, cytarabine
- Keywords
- recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular 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, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult unfavorable prognosis Hodgkin lymphoma, childhood unfavorable prognosis Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
sargramostimBiological
carmustineDrug
cyclophosphamideDrug
cytarabineDrug
etoposideDrug
methotrexateDrug
perfosfamideDrug
therapeutic hydrocortisoneDrug
allogeneic bone marrow transplantationProcedure or surgery
autologous bone marrow transplantationProcedure or surgery
in vitro-treated bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
syngeneic bone marrow transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2004 (estimated)
- Study startOct 1993
- Primary completionSep 2001
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roger Dansey, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002552
- Sponsor's protocol ID
- CDR0000063370
- Other IDs
- P30CA022453, WSU-D-701-87, NCI-V94-0364
- Status last verified
- Apr 2013
- First submitted
- 1 Nov 1999
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AUTOLOGOUS, ALLOGENEIC, OR SYNGENEIC BONE MARROW TRANSPLANTATION IN HODGKIN'S DISEASE, NON-HODGKIN'S LYMPHOMA, AND MULTIPLE MYELOMA
- ClinicalTrials.gov ID
- NCT00002552
- Acronym / sponsor ID
- CDR0000063370
- Keywords
- recurrent adult Hodgkin lymphoma, refractory multiple myeloma, recurrent small lymphocytic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1993
- Primary completion
- Sep 2001 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 24 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving a bone marrow transplant together with chemotherapy and to see how well it works in treating patients with refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.
Detailed description
OBJECTIVES: I. Assess the toxicities, response rate, and duration of response associated with high-dose cyclophosphamide, etoposide, carmustine or high-dose cyclophosphamide and total-body irradiation followed by autologous, allogeneic, or syngeneic bone marrow transplant in patients with refractory or high-risk non-Hodgkin's lymphoma, Hodgkin's disease, or multiple myeloma. II. Evaluate any prognostic factors.
OUTLINE: Patients with prior radiotherapy (greater than 2,000 cGy) receive cyclophosphamide IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by carmustine IV over 2 hours on day -3. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Patients with or without prior radiotherapy (less than 2,000 cGy) receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body irradiation on days -4 through -1. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Prior to autologous bone marrow transplantation and following myeloablative chemotherapy, patients undergo mobilization consisting of cytarabine subcutaneously every 12 hours for 6 doses. Approximately 24 hours later, patients receive sargramostim (GM-CSF) subcutaneously. Peripheral blood stem cells are collected every 1-3 days beginning when blood counts recover and continuing until sufficient number of cells are reached.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
| sargramostim | Biological | – |
| carmustine | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| etoposide | Drug | – |
| leucovorin calcium | Drug | – |
| methotrexate | Drug | – |
| perfosfamide | Drug | – |
| therapeutic hydrocortisone | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| in vitro-treated bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| syngeneic bone marrow transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Dansey, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, sargramostim and carmustine in people with Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.