Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006034
First received: July 5, 2000
Last updated: May 14, 2013
Last verified: January 2006
  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
Biological: keyhole limpet hemocyanin
Drug: doxorubicin hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Study Start Date: June 1998
Study Completion Date: March 2004
Arms Assigned Interventions
Experimental: Arm I
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
Given intradermally and IV
Active Comparator: Arm II
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006034     History of Changes
Other Study ID Numbers: INTRACEL-BCI-9804-04, CDR0000068047
Study First Received: July 5, 2000
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Doxorubicin
Keyhole-limpet hemocyanin
Liposomal doxorubicin
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014