Clinical trial NCT00043212: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
oncology
urology
hormone refractory prostate cancer
Lead sponsor: Northwest Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2002-08-08
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

* Hormone refractory prostate cancer (HRPC) \&#8211; progressive disease despite androgen deprivation and serum testosterone \<50ng/dL; progression defined as either:

  1. 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
  2. Progression of metastatic lesion on bone scan, or
  3. 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Orlando
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Peoria
country: United States
facility: St. Francis Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Las Vegas
country: United States
facility: Clinical Research Solutions
state: Nevada
city: Albany
country: United States
facility: Albany Regional Cancer Center
state: New York
city: Charlotte
country: United States
facility: Carolinas HealthCare System
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
References: