ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer

This study has been suspended.

Sponsored by: Intracel
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006034
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: doxorubicin hydrochloride
Drug: keyhole limpet hemocyanin
Phase III

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   June 1998

Arms Assigned Interventions
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.
Drug: keyhole limpet hemocyanin
Given intradermally and IV
Arm II: Active Comparator
Patients receive doxorubicin IV once weekly in weeks 1-6.
Drug: doxorubicin hydrochloride
Given IV

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006034

Locations
United States, Maryland
Intracel Resources, LLC    
      Frederick, Maryland, United States, 21701

Sponsors and Collaborators
Intracel

Investigators
Study Chair:     Michael G Hanna Jr., PhD     Intracel    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068047, INTRACEL-BCI-9804-04
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006034
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer  
recurrent bladder cancer  

Study placed in the following topic categories:
Urologic Diseases
Carcinoma in Situ
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Keyhole-limpet hemocyanin
Doxorubicin
Urinary tract neoplasm
Recurrence
Bladder neoplasm
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers