Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.

Intervention Type DRUG

CG1940/CG8711

Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Taxotere

Eligibility Criteria

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Inclusion Criteria

* Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease
* Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of \<60%.

Exclusion Criteria

* Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms)
* Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment.
* Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No