Clinical trial · Interventional
Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| keyhole limpet hemocyanin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Biological: keyhole limpet hemocyanin
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive doxorubicin IV once weekly in weeks 1-6.
- interventionNames
- Drug: doxorubicin hydrochloride
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available