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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00043212
• Other study ID #: DC3-HRPC, October 2001
• Status: Withdrawn
• Phase: Phase 3
• First received: August 6, 2002
• Last updated: April 30, 2013

Study information

• Verified date: April 2013
• Source: Northwest Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Hormone refractory prostate cancer (HRPC) – 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Dendritic cell immunotherapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Northwest Biotherapeutics

Country where clinical trial is conducted

United States, 

External Links

•   Northwest Biotherapeutics, Inc.