Bladder CancerPhase 2NCT01373294
Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer
A Phase 2 study testing Bacille Calmette-Guerrin (BCG) and Lenalidomide in people with Bladder Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purposes of this study are to: find out whether participants' cancer returns or gets worse while they are taking lenalidomide and Bacille Calmette-Guerrin (BCG); evaluate the safety and tolerability of the combination of lenalidomide and BCG; compare the cancer progression of participants taking lenalidomide and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Bacille Calmette-Guerrin (BCG) and Lenalidomide
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2011to 10 Dec 2018
- 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
Who may be able to join
- Prior BCG treatment for non-muscle invasive transitional cell carcinoma (TCC) last administered < 2 years for Ta high-grade, T1 high grade, Cis, or combination thereof
- Must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin.
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from providing informed consent
- Pregnant or breast feeding (lactating females must agree not to breast feed while taking lenalidomide)
- Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Use of any other experimental drug or therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
- Known hypersensitivity to BCG or tuberculosis vaccination
Show all 17Show fewer
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Any prior use of lenalidomide
- Concurrent use of other anti-cancer agents or treatments.
- Known presence of autoimmune disease or immune deficit or chronic disease such as HIV, infectious hepatitis (type B or C), or tuberculosis
- T2+, or N1+, or M+ disease
- Ta or T1 low grade disease only
- Concurrent use of chronic oral steroids, for any indication
- Recent history of deep venous thrombosis currently receiving anticoagulation therapy, with the clot event being in the last 6 months
- Diagnosis of any prior malignancies for the last 5 years with exception of definitively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast
- Life expectancy less than 1 year, by treating physician estimate
- Known exposure to person with active tuberculosis within 48 hours of starting treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Immune Modulation by Addition of Oral Lenalidomide to Intravesical BCG (Bacille Calmette-Guerrin) for Therapy of Non-muscle-invasive Transitional Cell Bladder Cancer
The purposes of this study are to:
- find out whether participants' cancer returns or gets worse while they are taking lenalidomide and Bacille Calmette-Guerrin (BCG);
- evaluate the safety and tolerability of the combination of lenalidomide and BCG;
- compare the cancer progression of participants taking lenalidomide and BCG versus participants taking only BCG
Read the detailed description
Investigators planned to screen approximately 100 people with bladder cancer who are 18 years of age or older throughout the United States for this study.
This is a multi-center study combining two marketed drugs, one of which has not been used previously in people with transitional cell cancer. Lenalidomide (Revlimid®) is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. Lenalidomide is currently being tested in a variety of cancer conditions. It is not approved by the FDA for use in people with bladder cancer, so in this case it is considered experimental.
The other drug used in this study is Bacille Calmette-Guerrin (BCG). BCG is approved by the FDA for use in people with bladder cancer.
- Conditions
- Bladder Cancer
- Being tested
- Bacille Calmette-Guerrin (BCG), Lenalidomide
- Keywords
- non-muscle-invasive, transitional cell, oral lenalidomide, intravesical
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacille Calmette-Guerrin (BCG)Drug
Also called BCG Vaccine
Participants will receive BCG instillations once per week for the first 6 weeks. At 3 months and 6 months, participants will receive BCG instillations once per week for three weeks.
LenalidomideDrug
Also called Revlimid®
Participants may also receive capsules of lenalidomide 10 mg to swallow once per day for 7 months. The study doctor will tell participants if they will be taking lenalidomide.
| Study group | Role | What they receive |
|---|---|---|
| A: Combination Arm | Experimental | Bacille Calmette-Guerrin (BCG) and lenalidomide.
Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group received BCG + lenalidomide) Receives: Drug: Bacille Calmette-Guerrin (BCG); Drug: Lenalidomide |
| B: Control Arm | Active comparator | Bacille Calmette-Guerrin (BCG) only.
Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.
This group was not eligible to receive the combination of BCG + lenalidomide. Receives: Drug: Bacille Calmette-Guerrin (BCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm A: Progression Free Survival (PFS)
The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison
Measured: 1 year
Secondary outcomes (1)
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of participants with treatment emergent AEs or SAEs per category. SAEs will be specifically labeled as such. Participants were assessed at monthly intervals (corresponding to Revlimid™ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated.
Measured: Duration of study treatment and follow-up - average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study start30 Nov 2011
- Primary completion9 Jan 2015
- Study completion10 Dec 2018
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.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Mayer Fishman, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373294
- Sponsor's protocol ID
- MCC-16295
- Other IDs
- RV-BLD-PI-0330
- Status last verified
- Aug 2019
- First submitted
- 13 Jun 2011
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Modulation by Addition of Oral Lenalidomide to Intravesical BCG (Bacille Calmette-Guerrin) for Therapy of Non-muscle-invasive Transitional Cell Bladder Cancer
- ClinicalTrials.gov ID
- NCT01373294
- Acronym / sponsor ID
- MCC-16295
- Conditions
- Bladder Cancer
- Keywords
- non-muscle-invasive, transitional cell, oral lenalidomide, intravesical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 30 Nov 2011 (actual)
- Primary completion
- 9 Jan 2015 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to:
- find out whether participants' cancer returns or gets worse while they are taking lenalidomide and Bacille Calmette-Guerrin (BCG);
- evaluate the safety and tolerability of the combination of lenalidomide and BCG;
- compare the cancer progression of participants taking lenalidomide and BCG versus participants taking only BCG
Detailed description
Investigators planned to screen approximately 100 people with bladder cancer who are 18 years of age or older throughout the United States for this study.
This is a multi-center study combining two marketed drugs, one of which has not been used previously in people with transitional cell cancer. Lenalidomide (Revlimid®) is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. Lenalidomide is currently being tested in a variety of cancer conditions. It is not approved by the FDA for use in people with bladder cancer, so in this case it is considered experimental.
The other drug used in this study is Bacille Calmette-Guerrin (BCG). BCG is approved by the FDA for use in people with bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Combination Arm | Experimental | Drug: Bacille Calmette-Guerrin (BCG), Drug: LenalidomideBacille Calmette-Guerrin (BCG) and lenalidomide. Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group received BCG + lenalidomide) |
| B: Control Arm | Active comparator | Drug: Bacille Calmette-Guerrin (BCG)Bacille Calmette-Guerrin (BCG) only. Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group was not eligible to receive the combination of BCG + lenalidomide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior BCG treatment for non-muscle invasive transitional cell carcinoma (TCC) last administered < 2 years for Ta high-grade, T1 high grade, Cis, or combination thereof
- Must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin.
Key exclusion criteria (17 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from providing informed consent
- Pregnant or breast feeding (lactating females must agree not to breast feed while taking lenalidomide)
- Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Use of any other experimental drug or therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
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 |
|---|---|---|
| Bacille Calmette-Guerrin (BCG)Also: BCG VaccineParticipants will receive BCG instillations once per week for the first 6 weeks. At 3 months and 6 months, participants will receive BCG instillations once per week for three weeks. | Drug | A: Combination Arm, B: Control Arm |
| LenalidomideAlso: Revlimid®Participants may also receive capsules of lenalidomide 10 mg to swallow once per day for 7 months. The study doctor will tell participants if they will be taking lenalidomide. | Drug | A: Combination Arm |
Primary outcome
Arm A: Progression Free Survival (PFS)
Time frame: 1 year
The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison
1 secondary outcome
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Duration of study treatment and follow-up - average of 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mayer Fishman, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research 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 Bacille Calmette-Guerrin (BCG) and Lenalidomide in people with Bladder Cancer, run by H. Lee Moffitt Cancer Center and Research 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 4 inclusion and 17 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 6 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 12 May 2016). 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?
Arm A: Progression Free Survival (PFS) (time frame: 1 year). 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 6 Aug 2019.