B-Cell LymphomaPhase 2NCT00054665
PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma
A Phase 2 study testing PS-341, Etoposide and Doxorubicin in people with B-Cell Lymphoma, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
This study will examine the safety and effectiveness of an experimental drug called Bortezomib (PS-341), given alone and in combination with a chemotherapy regimen called Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Filgrastim (EPOCH), in treating non-Hodgkin's B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Lymphoma
- What is being tested?
- PS-341, Etoposide and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2003to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- ELIGIBILITY CRITERIA:
Large B-cell lymphoma (subtypes: DLBCL (diffuse large B-cell lymphoma);
mediastinal (thymic) large B-cell lymphoma;
transformed large B-cell lymphoma;
follicular grade IIIB large B-cell lymphoma;
intravascular large B-cell lymphoma).
Confirmed pathological diagnosis at the treating institution.
Prior anthracycline-based treatment.
Age greater than or equal to 18 years.
Available tumor tissue for biopsy.
Eastern Cooperative Oncology Group (ECOG) performance 2 or better.
Major organ function: Absolute neutrophil count (ANC) greater than or equal to 1,000/microliters,
Platelet greater than or equal to 50,000/microliters,
creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 cc/min;
serum glutamic pyruvic transaminase (SGPT) less than 5 x upper limit of normal;
bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with Gilbert's syndrome as defined by greater than 80 percent unconjugated; unless impairment due to organ involvement by lymphoma.
Informed consent and willingness to use contraception by both men and women.
Not pregnant or nursing because of an unknown potential for teratogenic or abortifacient effects.
Both male and female patients must be willing to use adequate contraception.
Human immunodeficiency virus (HIV) serology negative.
HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of positive pharmacokinetic interactions with PS-341 or the combination of PS-341 and EPOCH.
Additionally, the biology of HIV associated DLBCL's is often quite different from HIV negative disease due to involvement of Epstein Barr Virus (EBV).
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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
Roswell Parck Cancer Institute
Buffalo, New York, 14263
About this study
Official title: PS-341 and PS-341 + Epoch Chemotherapy and Molecular Profiling in Relapsed or Refractory Diffuse Large B-Cell Lymphomas
This study will examine the safety and effectiveness of an experimental drug called Bortezomib (PS-341), given alone and in combination with a chemotherapy regimen called Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Filgrastim (EPOCH), in treating non-Hodgkin's B-cell lymphoma. In the laboratory, PS-341 kills lymphoma cells and makes them more sensitive to chemotherapy. The EPOCH treatment regimen includes the drugs doxorubicin, etoposide, vincristine, cyclophosphamide, prednisone, and filgrastim.
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.
Read more
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.
Read the detailed description
Diffuse large B-cell lymphomas (DLBCL) have been molecularly sub-classified into germinal center like B-cell (GCB) and activated B-cell like (ABC) DLBCL. Clinically, the ABC subtype has a significantly higher rate of drug resistance and lower survival. The ABC subtype has overexpression of nuclear factor-kappa B (NF-kB) with transcriptional activation of B cell lymphoma 2 (bcl-2), which may account for the drug resistance. The ability of NF-kB to inhibit responses to cancer therapeutic agents may also contribute to the refractory clinical behavior of ABC subtype, and inhibition of NF-kB can synergize with the chemotherapy to kill tumor cells. This protocol aims to study the affect of NF-kB inhibition, through proteasome inhibition by PS-341, on response to PS-341 and PS-341 with EPOCH chemotherapy in DLBCL. It will also assess the affect of PS-341 on NF-kB and BCL-2 tumor expression by microarray, and provide information on the specificity of PS-341.
- Conditions
- B-Cell Lymphoma
- Being tested
- PS-341, Etoposide, Doxorubicin, Vincristine, Cyclophosphamide
- Keywords
- BCL-2, NFK-B, Drug Resistance, Translational, Lymphoma, Large B-Cell Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS-341Drug
Also called Velcade, Bortezomib, LDB-341, MLN-341
1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
EtoposideDrug
Also called Vepesid, VP-16
50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion. Repeat cycle every 21 days.
DoxorubicinDrug
Also called Adriamycin
10 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
VincristineDrug
Also called Oncovin
0.4 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days.
CyclophosphamideDrug
Also called Cytoxan
750 mg/m^2 day IV day 5 bolus. Repeat cycle every 21 days.
PrednisoneDrug
Also called Deltasone
60 mg/m^2 by mouth twice a day days 1-5. Repeat cycle every 21 days.
FilgrastimDrug
Also called Neupogen
300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Part A: PS-341 Alone | Experimental | 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Receives: Drug: PS-341 |
| Part B: PS-341 & EPOCH | Experimental | 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. Receives: Drug: PS-341; Drug: Etoposide; Drug: Doxorubicin; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate
Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease
Measured: 18 weeks
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Measured: 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startFeb 2003
- Primary completionSep 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Wyndham Wilson, National Cancer Institute (NCI)
- Investigators
- Wyndham Wilson, M.D., Principal investigator, National Cancer Institute, National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054665
- Sponsor's protocol ID
- 030096
- Other IDs
- 03-C-0096
- Status last verified
- Aug 2012
- First submitted
- 5 Feb 2003
- Last updated
- 11 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 8717528Dunleavy 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.
PubMed 19380866
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PS-341 and PS-341 + Epoch Chemotherapy and Molecular Profiling in Relapsed or Refractory Diffuse Large B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00054665
- Acronym / sponsor ID
- 030096
- Conditions
- B-Cell Lymphoma
- Keywords
- BCL-2, NFK-B, Drug Resistance, Translational, Lymphoma, Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Feb 2003 (estimated)
- Results
- Posted 11 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and effectiveness of an experimental drug called Bortezomib (PS-341), given alone and in combination with a chemotherapy regimen called Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Filgrastim (EPOCH), in treating non-Hodgkin's B-cell lymphoma. In the laboratory, PS-341 kills lymphoma cells and makes them more sensitive to chemotherapy. The EPOCH treatment regimen includes the drugs doxorubicin, etoposide, vincristine, cyclophosphamide, prednisone, and filgrastim.
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
Diffuse large B-cell lymphomas (DLBCL) have been molecularly sub-classified into germinal center like B-cell (GCB) and activated B-cell like (ABC) DLBCL. Clinically, the ABC subtype has a significantly higher rate of drug resistance and lower survival. The ABC subtype has overexpression of nuclear factor-kappa B (NF-kB) with transcriptional activation of B cell lymphoma 2 (bcl-2), which may account for the drug resistance. The ability of NF-kB to inhibit responses to cancer therapeutic agents may also contribute to the refractory clinical behavior of ABC subtype, and inhibition of NF-kB can synergize with the chemotherapy to kill tumor cells. This protocol aims to study the affect of NF-kB inhibition, through proteasome inhibition by PS-341, on response to PS-341 and PS-341 with EPOCH chemotherapy in DLBCL. It will also assess the affect of PS-341 on NF-kB and BCL-2 tumor expression by microarray, and provide information on the specificity of PS-341.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: PS-341 Alone | Experimental | Drug: PS-3411.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks |
| Part B: PS-341 & EPOCH | Experimental | Drug: PS-341, Drug: Etoposide, Drug: Doxorubicin, Drug: Vincristine, Drug: Cyclophosphamide, Drug: Prednisone, Drug: FilgrastimPS-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| PS-341Also: Velcade, Bortezomib, LDB-341, MLN-3411.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks | Drug | Part A: PS-341 Alone, Part B: PS-341 & EPOCH |
| EtoposideAlso: Vepesid, VP-1650 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion. Repeat cycle every 21 days. | Drug | Part B: PS-341 & EPOCH |
| DoxorubicinAlso: Adriamycin10 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days. | Drug | Part B: PS-341 & EPOCH |
| VincristineAlso: Oncovin0.4 mg/m^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days. | Drug | Part B: PS-341 & EPOCH |
| CyclophosphamideAlso: Cytoxan750 mg/m^2 day IV day 5 bolus. Repeat cycle every 21 days. | Drug | Part B: PS-341 & EPOCH |
| PrednisoneAlso: Deltasone60 mg/m^2 by mouth twice a day days 1-5. Repeat cycle every 21 days. | Drug | Part B: PS-341 & EPOCH |
| FilgrastimAlso: Neupogen300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days. | Drug | Part B: PS-341 & EPOCH |
Primary outcome
Clinical Response Rate
Time frame: 18 weeks
Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease
Number of Participants With Adverse Events
Time frame: 43 months
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8717528Baldwin 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.
- Background: PubMed 19380866Dunleavy 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- CTCv2.0Link provided by the sponsor.
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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.
Wyndham Wilson, M.D. principal investigator
National Cancer Institute, National Institutes of Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PS-341, Etoposide and Doxorubicin in people with B-Cell Lymphoma, run by National Cancer Institute (NCI) at 2 sites 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 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 11 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Clinical Response Rate (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00054665, which also lists 2 linked publications.
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 11 Sep 2012.