Bladder AdenocarcinomaPhase 1NCT00072137
Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
A Phase 1 study testing Recombinant Fowlpox-TRICOM Vaccine, Recombinant Fowlpox GM-CSF Vaccine Adjuvant and Therapeutic Conventional Surgery in people with Bladder Adenocarcinoma and Bladder Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of vaccine therapy given directly into the bladder in treating patients who are undergoing surgery to remove all or part of the bladder. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Adenocarcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma
- What is being tested?
- Recombinant Fowlpox-TRICOM Vaccine, Recombinant Fowlpox GM-CSF Vaccine Adjuvant and Therapeutic Conventional Surgery
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Nov 2010
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a histologically documented bladder cancer including: transitional cell carcinoma, adenocarcinoma, or squamous cell carcinoma including carcinoma in situ (CIS) requiring cystectomy as a standard therapy for his/her tumor stage and be scheduled for this surgical procedure; patients should not be candidates for neoadjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Estimated life expectancy 6 or more months
- Prior therapy with intravesical Bacille Calmette-Guerin (BCG) and/or chemotherapy is allowed; patient must be at least 2 months beyond the instillation of any prior intravesical agent; patients should not have received systemic chemotherapy, radiation therapy, immunotherapy or systemic doses of steroids for at least 4 weeks prior to starting vaccination and have recovered from all acute toxicities of previous treatment; patients who have received neoadjuvant chemotherapy or radiation therapy to the bladder will be ineligible for this study
- Serum creatinine < 1.5 mg/dl or a creatinine clearance > 60 ml/min
- Bilirubin < 2.0 mg/dl
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- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 x normal range
- Absolute neutrophil count (ANC) > 1500/mm^3
- Platelets > 75000/mm^3
- Patients must not have known immunodeficiency disorder (acquired immunodeficiency syndrome [AIDS], severe combined immunodeficiency [SCID], Wiskott-Aldrich syndrome, etc.); study candidates will not be specifically screened for these, unless clinically indicated; if indicated, the referring physician will do the evaluation
- No active/uncontrolled infections
- Pregnant women or nursing mothers are ineligible; women with reproductive potential must have negative pregnancy test and are prohibited from sexual intercourse during this study (while receiving vaccine and at least 1 month following last dose); sexual abstinence (as opposed to contraception only) is necessary; similarly, male patients also must avoid sex for the same period as above
- No uncontrolled psychiatric illness or medical illness that the principal investigator feels will compromise the patient's tolerance of the study treatment
- Patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who cannot provide informed consent will not be eligible for the study
Who cannot join
- Altered immune-competence:
- Current or imminent steroid therapy or active antibiotic therapy (antibiotics given for prophylaxis are allowed)
- Immune deficiency disease or immunosuppressive therapy in the patient
- Present or history of an autoimmune disease in the patient (e.g. autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin)
- History of allergy to eggs as this vaccine is manufactured in chicken embryo cells
- Patients with any presence of liver function abnormalities, exposure to toxins, ongoing alcohol consumption, history of liver disease and/or history of hepatitis that may suggest persistent disease
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- Any concurrent active second malignancy or any malignant tumor within the prior 5 years with the exception of a superficial squamous or basal cell skin carcinoma or in situ carcinoma of the cervix or prostate
- Pregnancy
- Patients with active ischemic heart disease (i.e. class III or IV cardiac disease-New York Heart Association), a recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, ventricular arrhythmias or other arrhythmias requiring therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-TRICOM (rF-TRICOM) in Patients With Bladder Carcinoma Scheduled for Cystectomy
This phase I trial studies the side effects and best dose of vaccine therapy given directly into the bladder in treating patients who are undergoing surgery to remove all or part of the bladder. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving a vaccine directly into the bladder before surgery may cause a stronger immune response and keep tumor cells from coming back after surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety of intravesical administration of recombinant fowlpox virus encoding three different costimulatory molecules (B7.1, ICAM-1,LFA-3) called TRICOM (-rF-TRICOM) (recombinant fowlpox-TRICOM vaccine) and/or recombinant fowlpox encoding sargramostim (GM-CSF) (rF-GM-CSF) (recombinant fowlpox GM-CSF vaccine adjuvant) in the treatment of patients with carcinoma of the bladder scheduled for cystectomy.
SECONDARY OBJECTIVES:
- Determine the kinetics of viral infection and gene function as well as host response to intravesical recombinant fowlpox virus in the treatment of bladder cancer.
OUTLINE: This is a dose-escalation study. Patients are alternately assigned to Arms A and B. Once Arms A and B have finished accrual, patients are assigned to Arm C.
ARM A (closed to accrual 10/2004): Patients receive recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.
ARM B (closed to accrual 10/2004): Patients receive recombinant fowlpox-TRICOM vaccine intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.
ARM C: Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo cystectomy 4-6 days following the last intravesical instillation.
After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 3 years.
- Conditions
- Bladder Adenocarcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma, Recurrent Bladder Carcinoma, Stage I Bladder Cancer, Stage II Bladder Cancer
- Being tested
- Recombinant Fowlpox-TRICOM Vaccine, Recombinant Fowlpox GM-CSF Vaccine Adjuvant, Therapeutic Conventional Surgery, Pharmacological Study, Laboratory Biomarker Analysis
- 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.
Recombinant Fowlpox-TRICOM VaccineBiological
Also called Recombinant Fowlpox-TRICOM, rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox)
Given intravesically
Recombinant Fowlpox GM-CSF Vaccine AdjuvantBiological
Also called Fowlpox-Sargramostim, rF-GM-CSF, rF-Sargramostim
Given intravesically
Therapeutic Conventional SurgeryProcedure or surgery
Undergo cystectomy
Also called pharmacological studies
Correlative studies
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (rf-GM-CSF, closed to accrual 10/2004) | Experimental | Patients receive recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy. Receives: Biological: Recombinant Fowlpox GM-CSF Vaccine Adjuvant; Procedure: Therapeutic Conventional Surgery; Other: Pharmacological Study; Other: Laboratory Biomarker Analysis |
| Arm B (rf-TRICOM, closed to accrual 10/2004) | Experimental | Patients receive recombinant fowlpox-TRICOM vaccine intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy. Receives: Biological: Recombinant Fowlpox-TRICOM Vaccine; Procedure: Therapeutic Conventional Surgery; Other: Pharmacological Study; Other: Laboratory Biomarker Analysis |
| Arm C (rfTRICOM and rf-GM-CSF) | Experimental | Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy. Receives: Biological: Recombinant Fowlpox-TRICOM Vaccine; Biological: Recombinant Fowlpox GM-CSF Vaccine Adjuvant; Procedure: Therapeutic Conventional Surgery; Other: Pharmacological Study; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
Measured: Up to 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startOct 2003
- Primary completionDec 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder AdenocarcinomaStudies 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert Weiss, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072137
- Sponsor's protocol ID
- NCI-2009-00020
- Other IDs
- NCI-2009-00020, CDR0000335473, 050301, 5585, U01CA132194, P30CA072720
- Status last verified
- Aug 2013
- First submitted
- 4 Nov 2003
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-TRICOM (rF-TRICOM) in Patients With Bladder Carcinoma Scheduled for Cystectomy
- ClinicalTrials.gov ID
- NCT00072137
- Acronym / sponsor ID
- NCI-2009-00020
- Conditions
- Bladder Adenocarcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma, Recurrent Bladder Carcinoma, Stage I Bladder Cancer, Stage II Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Nov 2003 (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.
This phase I trial studies the side effects and best dose of vaccine therapy given directly into the bladder in treating patients who are undergoing surgery to remove all or part of the bladder. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving a vaccine directly into the bladder before surgery may cause a stronger immune response and keep tumor cells from coming back after surgery.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety of intravesical administration of recombinant fowlpox virus encoding three different costimulatory molecules (B7.1, ICAM-1,LFA-3) called TRICOM (-rF-TRICOM) (recombinant fowlpox-TRICOM vaccine) and/or recombinant fowlpox encoding sargramostim (GM-CSF) (rF-GM-CSF) (recombinant fowlpox GM-CSF vaccine adjuvant) in the treatment of patients with carcinoma of the bladder scheduled for cystectomy.
SECONDARY OBJECTIVES:
- Determine the kinetics of viral infection and gene function as well as host response to intravesical recombinant fowlpox virus in the treatment of bladder cancer.
OUTLINE: This is a dose-escalation study. Patients are alternately assigned to Arms A and B. Once Arms A and B have finished accrual, patients are assigned to Arm C.
ARM A (closed to accrual 10/2004): Patients receive recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.
ARM B (closed to accrual 10/2004): Patients receive recombinant fowlpox-TRICOM vaccine intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.
ARM C: Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo cystectomy 4-6 days following the last intravesical instillation.
After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 3 years.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (rf-GM-CSF, closed to accrual 10/2004) | Experimental | Biological: Recombinant Fowlpox GM-CSF Vaccine Adjuvant, Procedure: Therapeutic Conventional Surgery, Other: Pharmacological Study, Other: Laboratory Biomarker AnalysisPatients receive recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy. |
| Arm B (rf-TRICOM, closed to accrual 10/2004) | Experimental | Biological: Recombinant Fowlpox-TRICOM Vaccine, Procedure: Therapeutic Conventional Surgery, Other: Pharmacological Study, Other: Laboratory Biomarker AnalysisPatients receive recombinant fowlpox-TRICOM vaccine intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy. |
| Arm C (rfTRICOM and rf-GM-CSF) | Experimental | Biological: Recombinant Fowlpox-TRICOM Vaccine, Biological: Recombinant Fowlpox GM-CSF Vaccine Adjuvant, Procedure: Therapeutic Conventional Surgery, Other: Pharmacological Study, Other: Laboratory Biomarker AnalysisPatients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have a histologically documented bladder cancer including: transitional cell carcinoma, adenocarcinoma, or squamous cell carcinoma including carcinoma in situ (CIS) requiring cystectomy as a standard therapy for his/her tumor stage and be scheduled for this surgical procedure; patients should not be candidates for neoadjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Estimated life expectancy 6 or more months
- Prior therapy with intravesical Bacille Calmette-Guerin (BCG) and/or chemotherapy is allowed; patient must be at least 2 months beyond the instillation of any prior intravesical agent; patients should not have received systemic chemotherapy, radiation therapy, immunotherapy or systemic doses of steroids for at least 4 weeks prior to starting vaccination and have recovered from all acute toxicities of previous treatment; patients who have received neoadjuvant chemotherapy or radiation therapy to the bladder will be ineligible for this study
- Serum creatinine < 1.5 mg/dl or a creatinine clearance > 60 ml/min
Key exclusion criteria (9 listed)
- Altered immune-competence:
- Present or history of an autoimmune disease in the patient (e.g. autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin)
- History of allergy to eggs as this vaccine is manufactured in chicken embryo cells
- Patients with any presence of liver function abnormalities, exposure to toxins, ongoing alcohol consumption, history of liver disease and/or history of hepatitis that may suggest persistent disease
- Any concurrent active second malignancy or any malignant tumor within the prior 5 years with the exception of a superficial squamous or basal cell skin carcinoma or in situ carcinoma of the cervix or prostate
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 |
|---|---|---|
| Recombinant Fowlpox-TRICOM VaccineAlso: Recombinant Fowlpox-TRICOM, rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox)Given intravesically | Biological | Arm B (rf-TRICOM, closed to accrual 10/2004), Arm C (rfTRICOM and rf-GM-CSF) |
| Recombinant Fowlpox GM-CSF Vaccine AdjuvantAlso: Fowlpox-Sargramostim, rF-GM-CSF, rF-SargramostimGiven intravesically | Biological | Arm A (rf-GM-CSF, closed to accrual 10/2004), Arm C (rfTRICOM and rf-GM-CSF) |
| Therapeutic Conventional SurgeryUndergo cystectomy | Procedure or surgery | Arm A (rf-GM-CSF, closed to accrual 10/2004), Arm B (rf-TRICOM, closed to accrual 10/2004), Arm C (rfTRICOM and rf-GM-CSF) |
| Pharmacological StudyAlso: pharmacological studiesCorrelative studies | Other | Arm A (rf-GM-CSF, closed to accrual 10/2004), Arm B (rf-TRICOM, closed to accrual 10/2004), Arm C (rfTRICOM and rf-GM-CSF) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (rf-GM-CSF, closed to accrual 10/2004), Arm B (rf-TRICOM, closed to accrual 10/2004), Arm C (rfTRICOM and rf-GM-CSF) |
Primary outcome
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
Time frame: Up to 39 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
Robert Weiss principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Fowlpox-TRICOM Vaccine, Recombinant Fowlpox GM-CSF Vaccine Adjuvant and Therapeutic Conventional Surgery in people with Bladder Adenocarcinoma and Bladder Squamous Cell Carcinoma, run by National Cancer Institute (NCI) 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 14 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 Dec 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC) (time frame: Up to 39 days). 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 23 Dec 2014.