Waldenstrom's MacroglobulinemiaPhase 2NCT00165295
Sildenafil Citrate in Waldenstrom's Macroglobulinemia
A Phase 2 study testing Sildenafil citrate (Viagra) in people with Waldenstrom's Macroglobulinemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom's Macroglobulinemia
- What is being tested?
- Sildenafil citrate (Viagra)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
- Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of > 2 times the upper limit of each institution's normal value
- Slowly progressing disease not requiring therapy for at least 3-6 months
- ECOG performance status 0,1 or 2
- Total bilirubin < 2 x ULN
- SGOT < 3 x ULN
- Creatinine < 2 x ULN
Who cannot join
- Pregnant or breast-feeding women
- Patients who are using organic nitrates or alpha-blockers
- Grade III/IV cardiac problems
- Resting hypotension (BP < 90/50) or hypertension (BP > 170/110)
- Cardiac failure or coronary artery disease causing unstable angina
- Evidence of left ventricular outflow obstruction
Show all 13Show fewer
- Impaired autonomic control of blood pressure
- Sickle cell anemia
- History of priapism
- Severe and/or uncontrolled medical disease
- Known chronic liver disease
- Currently using ritonavir
- History of retinal pigmentosa
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia
The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy WM cells.
Read the detailed description
- Sildenafil will be given orally (at home) at a reduced dose for the first week, then each week for 3 more weeks, the dose will be increased. If the patient has no major side effects, then they will receive the maximal dose for 2 years. If they have major side effects, then the dose of the drug might be lowered or the drug stopped.
- Sildenafil will be continued until their is disease progression or serious side effects.
- While patients are receiving sildenafil, they will be seen in the clinic on months 1,2,9,15 and 21 for blood tests and a subject questionnaire. They will also be seen on months 3,6,12,18 and 24 for a physical exam, blood test, physical assessment test, CT scans of chest, abdomen and pelvis, and a subject questionnaire.
- At the end of the study (month 24) a physical exam, blood tests, physical assessment test and a questionnaire will be conducted.
- Follow-up includes clinic visits at month 27,33,39 and 45 for blood tests and a questionnaire as well as visits at month 30,36,42 and 48 for physical exam, blood tests, physical assessment test, bone marrow aspirate and biopsy, CT scans of chest, abdomen and pelvis, and a questionnaire.
- Conditions
- Waldenstrom's Macroglobulinemia
- Being tested
- Sildenafil citrate (Viagra)
- Keywords
- sildenafil citrate, Viagra, Waldenstrom's macroglobulinemia
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrate (Viagra)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom's MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Investigators
- Steven P. Treon, MD, MA, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165295
- Sponsor's protocol ID
- 05-087
- Status last verified
- Jun 2011
- First submitted
- 9 Sep 2005
- Last updated
- 27 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT00165295
- Acronym / sponsor ID
- 05-087
- Conditions
- Waldenstrom's Macroglobulinemia
- Keywords
- sildenafil citrate, Viagra, Waldenstrom's macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Sep 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Sep 2005 (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.
The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy WM cells.
Detailed description
- Sildenafil will be given orally (at home) at a reduced dose for the first week, then each week for 3 more weeks, the dose will be increased. If the patient has no major side effects, then they will receive the maximal dose for 2 years. If they have major side effects, then the dose of the drug might be lowered or the drug stopped.
- Sildenafil will be continued until their is disease progression or serious side effects.
- While patients are receiving sildenafil, they will be seen in the clinic on months 1,2,9,15 and 21 for blood tests and a subject questionnaire. They will also be seen on months 3,6,12,18 and 24 for a physical exam, blood test, physical assessment test, CT scans of chest, abdomen and pelvis, and a subject questionnaire.
- At the end of the study (month 24) a physical exam, blood tests, physical assessment test and a questionnaire will be conducted.
- Follow-up includes clinic visits at month 27,33,39 and 45 for blood tests and a questionnaire as well as visits at month 30,36,42 and 48 for physical exam, blood tests, physical assessment test, bone marrow aspirate and biopsy, CT scans of chest, abdomen and pelvis, and a questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
- Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of > 2 times the upper limit of each institution's normal value
- Slowly progressing disease not requiring therapy for at least 3-6 months
- ECOG performance status 0,1 or 2
- Total bilirubin < 2 x ULN
Key exclusion criteria (13 listed)
- Pregnant or breast-feeding women
- Patients who are using organic nitrates or alpha-blockers
- Grade III/IV cardiac problems
- Resting hypotension (BP < 90/50) or hypertension (BP > 170/110)
- Cardiac failure or coronary artery disease causing unstable angina
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 |
|---|---|---|
| Sildenafil citrate (Viagra) | Drug | – |
Primary outcome
To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.
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 27 Jun 2011.
Related trials for Waldenstrom's Macroglobulinemia
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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.
Steven P. Treon, MD, MA, PhD principal investigator
Dana-Farber 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 Sildenafil citrate (Viagra) in people with Waldenstrom's Macroglobulinemia, run by Dana-Farber 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?
The sponsor lists 7 inclusion and 13 exclusion criteria. 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 27 Jun 2011. 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.
What does the primary outcome measure?
To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.. It is what the study was designed to measure, not a finding.
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 27 Jun 2011.