PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma
NCT ID: NCT00054665
Last Updated: 2012-09-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2003-02-28
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients 18 years of age and older with an aggressive non-Hodgkin's lymphoma that has relapsed after treatment or is not responding to chemotherapy may be eligible for this study. Candidates will be screened with a medical history and physical examination. Other tests that may be required include blood and urine tests; lung function studies; imaging tests such as magnetic resonance imaging, computed tomography and x-rays; and biopsy (surgical removal of a small tissue sample) of tumor, bone marrow, or other tissue.
Upon entering the study, all participants will receive PS-341. The drug is given as a 3- to 5-second intravenous (through a vein) injection twice a week for 2 weeks. This is followed by a 1-week rest. Each 3-week period comprises one treatment cycle. The number of cycles a patient receives depends on how well he or she responds to the drug. Patients who do not have a complete remission or whose tumor grows on this therapy will be offered PS-341 in combination with up to six cycles of EPOCH chemotherapy. The treatment for patients taking PS-341 plus EPOCH is as follows:
* PS-341, given by 3- to 5-second intravenous (IV) injection on days 1 and 4 of each cycle.
* Doxorubicin, etoposide, and vincristine, given by continuous IV infusion over 4 days, beginning on day 1 and ending on day 5 of each cycle. The drugs are delivered through a lightweight portable infusion pump to an indwelling IV catheter (plastic tube) in a vein.
* Cyclophosphamide, given by IV infusion over 15 minutes on day 5 of each cycle.
* Prednisone, given by mouth (pills) twice a day on days 1 through 5 of each cycle.
* Filgrastim, given by injection under the skin starting on day 6 of each cycle and continuing until the white blood cell count increases or until day 19 of the cycle.
Patients also take a combination of antibiotics 3 days a week during EPOCH to prevent infection while resistance is lowered because of the chemotherapy. Etoposide, doxorubicin, and cyclophosphamide doses are adjusted as needed, based on white blood cell counts of the previous cycle. The first patients in the study will receive a low dose of PS-341. The dose will be increased in subsequent small groups of patients as long as the preceding dose is well tolerated.
Drug therapy for patients who are candidates for bone marrow transplant will be tailored to permit transplantation. Patients who are not eligible for or who choose not to have a bone marrow transplant will be followed at the National Institutes of Health (NIH) every 3 months the first year, every 4 months the second year, every 6 months the third year, and then once a year until their disease progresses or the study ends. Patients may have tumor and bone marrow biopsies, blood draws, and computed tomography (CT) scans periodically to evaluate disease status and drug side effects.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: PS-341 Alone
1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
PS-341
1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
Part B: PS-341 & EPOCH
PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycles every 21 days.
PS-341
1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
Etoposide
50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion. Repeat cycle every 21 days.
Doxorubicin
10 mg/m\^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
Vincristine
0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
Cyclophosphamide
750 mg/m\^2 day IV day 5 bolus. Repeat cycle every 21 days.
Prednisone
60 mg/m\^2 by mouth twice a day days 1-5. Repeat cycle every 21 days.
Filgrastim
300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycle every 21 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PS-341
1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
Etoposide
50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion. Repeat cycle every 21 days.
Doxorubicin
10 mg/m\^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
Vincristine
0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
Cyclophosphamide
750 mg/m\^2 day IV day 5 bolus. Repeat cycle every 21 days.
Prednisone
60 mg/m\^2 by mouth twice a day days 1-5. Repeat cycle every 21 days.
Filgrastim
300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycle every 21 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
Hepatitis B surface antigen negative.
No symptomatic cardiac disease or cardiac ejection fraction less than 40 percent (in patients receiving EPOCH).
No active central nervous system (CNS) lymphoma.
No systemic cytotoxic or experimental treatments within 4 weeks of treatment.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wyndham Wilson
Dr. Wyndham Wilson
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wyndham Wilson, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, National Institutes of Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Institute (NCI)
Bethesda, Maryland, United States
Roswell Parck Cancer Institute
Buffalo, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Baldwin AS Jr. The NF-kappa B and I kappa B proteins: new discoveries and insights. Annu Rev Immunol. 1996;14:649-83. doi: 10.1146/annurev.immunol.14.1.649.
Dunleavy K, Pittaluga S, Czuczman MS, Dave SS, Wright G, Grant N, Shovlin M, Jaffe ES, Janik JE, Staudt LM, Wilson WH. Differential efficacy of bortezomib plus chemotherapy within molecular subtypes of diffuse large B-cell lymphoma. Blood. 2009 Jun 11;113(24):6069-76. doi: 10.1182/blood-2009-01-199679. Epub 2009 Apr 20.
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
CTCv2.0
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
03-C-0096
Identifier Type: -
Identifier Source: secondary_id
030096
Identifier Type: -
Identifier Source: org_study_id
NCT00057902
Identifier Type: -
Identifier Source: nct_alias