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A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer (HRPC)

Primary Purpose

Hormone Refractory Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Mycobacterium w.

Docetaxel

About this trial

This is an interventional treatment trial for Hormone Refractory Prostate Cancer focused on measuring HRPC, Metastatic Hormone Refractory Prostate Cancer, Docetaxel, Mycobacterium w

Eligibility Criteria

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

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
Disease progression during antiandrogen therapy, having surgical or medical castration status.
Karnofsky Performance Status 50-100
Normal cardiac function
Life expectancy at least 24 weeks.
Laboratory criteria for eligibility will include
A neutrophil count of at least 1500 per cubic millimeter
A hemoglobin level of at least 9 gm%
A platelet count of at least 1000,000 per cubic millimeter.
A total bilirubin not grater than 1.5 times the upper limit of the normal range for each institution.
Serum creatinine levels not more than 1.5 times the upper limit of the normal range
Written informed consent

Exclusion Criteria:

Prior treatment with cytotoxic agents or radioisotopes
Estrogen use for at least three months
History of another cancer within the preceding five years (except basal or squamous-cell skin cancer)
Brain or leptomeningeal metastases
Symptomatic peripheral neuropathy of grade 2 or higher
Uncontrolled intercurrent illness that would limit compliance with study requirements

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Docetaxel+Mw

Docetaxel

Outcomes

Primary Outcome Measures

Median Survival time

Time to Tumor Progression

Secondary Outcome Measures

hematological toxicity, PSA levels, Quality of Life

Full Information

NCT ID

NCT00525408

First Posted

September 1, 2007

Last Updated

March 9, 2012

Sponsor

Cadila Pharnmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00525408

Brief Title

A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer

Acronym

HRPC

Official Title

Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Docetaxel Versus Docetaxel in Metastatic Hormone Refractory Prostate Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Why Stopped

Interim Analysis report indicates trial futility

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cadila Pharnmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study proposed the comparison the overall survival, hematological toxicity, pain reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from different parts of India.

Detailed Description

Prostate Cancer is a common health issue facing men worldwide in most of the patients cancer will shrink with hormonal therapy. In some cases cancer returns or continues to grow despite very low levels of circulating male hormones, which is called Androgen-Independent Prostate Cancer (AIPC) or Hormone Refractory Prostate Cancer (HRPC). Mycobacterium w is known to share multiple antigen including PSA. It administration is associated with antigen specific generation of cell mediated immunity. Docetaxel is found to useful in management of metastatic hormone refractory prostate cancer, which is associated with improved survival, tumor progression free survival with reduction in pain, serum PSA and improvement in quality of life. Cyclophosphamide 300mg/sq.m will be used to eliminate T-regulatory cell responsible immuno suppression. The vaccine Mycobacterium w will be administered on a day following cyclophosphamide. For better initiation of immune responses Docetaxel will be given seven days following first dose of Mycobacterium w.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hormone Refractory Prostate Cancer

Keywords

HRPC, Metastatic Hormone Refractory Prostate Cancer, Docetaxel, Mycobacterium w

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Docetaxel+Mw

Arm Title

Arm Type

Active Comparator

Arm Description

Docetaxel

Intervention Type

Biological

Intervention Name(s)

Mycobacterium w.

Intervention Description

Immunomodulator

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Chemotherapeutic agent

Primary Outcome Measure Information:

Title

Median Survival time

Time Frame

12 months

Title

Time to Tumor Progression

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

hematological toxicity, PSA levels, Quality of Life

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease. Disease progression during antiandrogen therapy, having surgical or medical castration status. Karnofsky Performance Status 50-100 Normal cardiac function Life expectancy at least 24 weeks. Laboratory criteria for eligibility will include A neutrophil count of at least 1500 per cubic millimeter A hemoglobin level of at least 9 gm% A platelet count of at least 1000,000 per cubic millimeter. A total bilirubin not grater than 1.5 times the upper limit of the normal range for each institution. Serum creatinine levels not more than 1.5 times the upper limit of the normal range Written informed consent Exclusion Criteria: Prior treatment with cytotoxic agents or radioisotopes Estrogen use for at least three months History of another cancer within the preceding five years (except basal or squamous-cell skin cancer) Brain or leptomeningeal metastases Symptomatic peripheral neuropathy of grade 2 or higher Uncontrolled intercurrent illness that would limit compliance with study requirements

Overall Study Officials: