NCT00006034

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1998

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

May 15, 2013

Status Verified

January 1, 2006

First QC Date

July 5, 2000

Last Update Submit

May 14, 2013

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerrecurrent bladder cancer

Study Arms (2)

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.

Biological: keyhole limpet hemocyanin

Arm II

ACTIVE COMPARATOR

Patients receive doxorubicin IV once weekly in weeks 1-6.

Drug: doxorubicin hydrochloride

Interventions

keyhole limpet hemocyaninBIOLOGICAL

Given intradermally and IV

Arm I
doxorubicin hydrochlorideDRUG

Given IV

Arm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Intracel Resources, LLC

Frederick, Maryland, 21701, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

keyhole-limpet hemocyaninDoxorubicin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Michael G Hanna Jr., PhD

    Intracel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2000

First Posted

October 7, 2003

Study Start

June 1, 1998

Study Completion

March 1, 2004

Last Updated

May 15, 2013

Record last verified: 2006-01

Locations

US(1)