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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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).

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

DC3-HRPC, October 2001

NCT ID:

NCT00043212

Start Date:

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • oncology
  • urology
  • hormone refractory prostate cancer
  • Prostatic Neoplasms

Name

Location

Louisiana State UniversityNew Orleans, Louisiana  70112-2282
Cleveland Clinic FoundationCleveland, Ohio  44195
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Albany Regional Cancer CenterAlbany, New York  12208
St. Francis Medical CenterPeoria, Illinois  61637
Highlands Oncology GroupSpringdale, Arkansas  72764
Mary Crowley Medical Research CenterDallas, Texas  75246
Tyler Cancer CenterTyler, Texas  75702
University of UtahSalt Lake City, Utah  
Cancer Care NorthwestSpokane, Washington  99202
University of California, Los AngelesLos Angeles, California  
University of California, San Diego Medical CenterSan Diego, California  
Cancer Centers of Florida, P.A.Orlando, Florida  
Clinical Research SolutionsLas Vegas, Nevada  
Carolinas HealthCare SystemCharlotte, North Carolina