Bladder CancerPhase 3NCT00006034
Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer
A Phase 3 study testing keyhole limpet hemocyanin and doxorubicin hydrochloride in people with Bladder Cancer, run by Intracel at 1 site in United States.
Trial summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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?
- keyhole limpet hemocyanin and doxorubicin hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 1998to Mar 2004
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed carcinoma in situ of the bladder with or without resected superficial papillary tumor
- Biopsy within 3 months of study with or without positive urinary cytology within 6 weeks of study
- Cystoscopy within 3 months of study
- Negative imaging study of the ureters and kidneys within 6 months of study
- BCG refractory disease
- Received and failed at least 1 prior induction course consisting of BCG weekly for 6 weeks OR
- BCG intolerant
- Unable to receive an adequate course of intravesical BCG due to extreme toxicity
- Opted against or medically contraindicated to cystectomy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 11 g/dL
Hepatic
- Bilirubin normal
- SGOT/SGPT normal
Renal
- Creatinine no greater than 1.5 times upper limit of normal
Cardiovascular
- No severe cardiovascular disease
Other
- No other severe disease
- No other malignancy within the past 5 years except basal or squamous cell skin cancer or noninvasive cancer of the cervix
- No evidence of autoimmune disease, known immune deficiency, or immunosuppression
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior keyhole limpet hemocyanin immune activator
Chemotherapy
- No prior doxorubicin
- At least 3 months since prior mitomycin
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent steroids
Radiotherapy
- At least 4 months since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 4 weeks since prior intravesical therapy
- At least 3 months since prior investigational agents
- No concurrent cytotoxic immunosuppressive agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter Phase III Trial Evaluating the Efficacy and Safety of BCI-ImmuneActivator Versus Adriamycin in BCG Refractory or Intolerant Patients With Carcinoma in Situ With or Without Resected Superficial Papillary Bladder Cancer
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether keyhole limpet hemocyanin is more effective than doxorubicin for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin with that of doxorubicin in treating patients who have bladder cancer that has not responded to BCG or in those patients who cannot tolerate BCG.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of BCI-ImmuneActivator™ (keyhole limpet hemocyanin) versus doxorubicin in BCG refractory or intolerant patients with carcinoma in situ with or without resected superficial papillary bladder cancer.
- Compare the toxicity and safety of these treatments in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and prior BCG response (refractory vs intolerant). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive a sensitizing dose of keyhole limpet hemocyanin (KLH) intradermally at week -2 followed by induction KLH IV once weekly at weeks 1-6. Patients with partial or no response receive IV KLH reinduction therapy once weekly at weeks 13-18. Patients with complete response receive IV KLH maintenance therapy monthly at weeks 13, 17, and 21, and then at months 6-12.
- Arm II: Patients receive doxorubicin IV once weekly at weeks 1-6. Patients with complete response receive maintenance therapy comprising doxorubicin IV at weeks 13, 17, and 21 and months 6-12.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years, and then every 6 months for 1 year. (Patient total participation in this study may last as long as 42 months.)
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
- Conditions
- Bladder Cancer
- Being tested
- keyhole limpet hemocyanin, doxorubicin hydrochloride
- Keywords
- stage 0 bladder cancer, recurrent bladder cancer
- 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.
keyhole limpet hemocyaninBiological
Given intradermally and IV
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive a sensitizing dose of keyhole limpet hemocyanin (KLH) intradermally in week 2 followed by induction KLH IV once weekly in weeks 1-6. Patients with partial or no response receive IV KLH reinduction therapy once weekly in weeks 13-18. Patients with complete response receive IV KLH maintenance therapy monthly in weeks 13, 17, and 21, and then in months 6-12. Receives: Biological: keyhole limpet hemocyanin |
| Arm II | Active comparator | Patients receive doxorubicin IV once weekly in weeks 1-6. Receives: Drug: doxorubicin hydrochloride |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2003 (estimated)
- Study startJun 1998
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Intracel
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael G Hanna Jr., PhD, Study chair, Intracel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006034
- Sponsor's protocol ID
- INTRACEL-BCI-9804-04
- Other IDs
- CDR0000068047
- Status last verified
- Jan 2006
- First submitted
- 5 Jul 2000
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Phase III Trial Evaluating the Efficacy and Safety of BCI-ImmuneActivator Versus Adriamycin in BCG Refractory or Intolerant Patients With Carcinoma in Situ With or Without Resected Superficial Papillary Bladder Cancer
- ClinicalTrials.gov ID
- NCT00006034
- Acronym / sponsor ID
- INTRACEL-BCI-9804-04
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer, recurrent bladder cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- IntracelIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Study completion
- Mar 2004 (actual)
- First posted
- 7 Oct 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.
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether keyhole limpet hemocyanin is more effective than doxorubicin for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of keyhole limpet hemocyanin with that of doxorubicin in treating patients who have bladder cancer that has not responded to BCG or in those patients who cannot tolerate BCG.
Detailed description
OBJECTIVES:
- Compare the efficacy of BCI-ImmuneActivator™ (keyhole limpet hemocyanin) versus doxorubicin in BCG refractory or intolerant patients with carcinoma in situ with or without resected superficial papillary bladder cancer.
- Compare the toxicity and safety of these treatments in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and prior BCG response (refractory vs intolerant). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive a sensitizing dose of keyhole limpet hemocyanin (KLH) intradermally at week -2 followed by induction KLH IV once weekly at weeks 1-6. Patients with partial or no response receive IV KLH reinduction therapy once weekly at weeks 13-18. Patients with complete response receive IV KLH maintenance therapy monthly at weeks 13, 17, and 21, and then at months 6-12.
- Arm II: Patients receive doxorubicin IV once weekly at weeks 1-6. Patients with complete response receive maintenance therapy comprising doxorubicin IV at weeks 13, 17, and 21 and months 6-12.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years, and then every 6 months for 1 year. (Patient total participation in this study may last as long as 42 months.)
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: keyhole limpet hemocyaninPatients receive a sensitizing dose of keyhole limpet hemocyanin (KLH) intradermally in week 2 followed by induction KLH IV once weekly in weeks 1-6. Patients with partial or no response receive IV KLH reinduction therapy once weekly in weeks 13-18. Patients with complete response receive IV KLH maintenance therapy monthly in weeks 13, 17, and 21, and then in months 6-12. |
| Arm II | Active comparator | Drug: doxorubicin hydrochloridePatients receive doxorubicin IV once weekly in weeks 1-6. |
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 |
|---|---|---|
| keyhole limpet hemocyaninGiven intradermally and IV | Biological | Arm I |
| doxorubicin hydrochlorideGiven IV | Drug | Arm II |
Primary outcome
Not reported in the source record.
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 15 May 2013.
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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.
Michael G Hanna Jr., PhD study chair
Intracel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing keyhole limpet hemocyanin and doxorubicin hydrochloride in people with Bladder Cancer, run by Intracel 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?
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 15 May 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 15 May 2013.