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Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dendritic cell immunotherapy
Sponsored by
Northwest Biotherapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, oncology, urology, hormone refractory prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria Hormone refractory prostate cancer (HRPC) &#8211; progressive disease despite androgen deprivation and serum testosterone <50ng/dL; progression defined as either: Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement >2.0 ng/ml; or Progression of metastatic lesion on bone scan, or Progression of lymph node metastasis by CT scan. Zubrod or ECOG performance status of 0-1. Three or fewer bone metastases on a bone scan with minimal symptoms. No lymph node lesions greater than 3.0 cm at longest diameter. Adequate hematological, hepatic and renal function. Exclusion Criteria History of other active malignancy. Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months. Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment. Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness. Prior splenectomy. History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test. History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke. History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV. Impending untreated spinal cord compression or urinary outlet obstruction. Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).

Sites / Locations

  • Highlands Oncology Group
  • University of California, Los Angeles
  • University of California, San Diego Medical Center
  • Walter Reed Army Medical Center
  • Cancer Centers of Florida, P.A.
  • St. Francis Medical Center
  • Louisiana State University
  • Clinical Research Solutions
  • Albany Regional Cancer Center
  • Carolinas HealthCare System
  • Cleveland Clinic Foundation
  • Mary Crowley Medical Research Center
  • Tyler Cancer Center
  • University of Utah
  • Cancer Care Northwest
  • St. Luke's Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 6, 2002
Last Updated
April 30, 2013
Sponsor
Northwest Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00043212
Brief Title
Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.
Official Title
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Redirection of company goals
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwest Biotherapeutics

4. Oversight

5. Study Description

Brief Summary
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Detailed Description
Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain & swelling at the injection site, and short-lived headache, fever & fatigue. Full details are available in the informed consent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, oncology, urology, hormone refractory prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dendritic cell immunotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Hormone refractory prostate cancer (HRPC) &#8211; progressive disease despite androgen deprivation and serum testosterone <50ng/dL; progression defined as either: Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement >2.0 ng/ml; or Progression of metastatic lesion on bone scan, or Progression of lymph node metastasis by CT scan. Zubrod or ECOG performance status of 0-1. Three or fewer bone metastases on a bone scan with minimal symptoms. No lymph node lesions greater than 3.0 cm at longest diameter. Adequate hematological, hepatic and renal function. Exclusion Criteria History of other active malignancy. Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months. Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment. Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness. Prior splenectomy. History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test. History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke. History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV. Impending untreated spinal cord compression or urinary outlet obstruction. Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
Facility Information:
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of California, San Diego Medical Center
City
San Diego
State/Province
California
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Cancer Centers of Florida, P.A.
City
Orlando
State/Province
Florida
Country
United States
Facility Name
St. Francis Medical Center
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Louisiana State University
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Clinical Research Solutions
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Albany Regional Cancer Center
City
Albany
State/Province
New York
Country
United States
Facility Name
Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nwbio.com
Description
Northwest Biotherapeutics, Inc.

Learn more about this trial

Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.

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