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

Hormone Refractory Prostate Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00525408
• Other study ID #: CR-60/1260
• Status: Terminated
• Phase: Phase 2
• First received: September 1, 2007
• Last updated: March 9, 2012
• Start date: November 2007
• Est. completion date: January 2013

Study information

• Verified date: March 2012
• Source: Cadila Pharnmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer
• Mycobacterium Infections
• Prostatic Neoplasms

Intervention

Biological:
• Mycobacterium w.
Immunomodulator

Drug:
• Docetaxel
Chemotherapeutic agent

Locations

Country	Name	City	State
India	Kidwai Memorial Institute of Oncology	Bangalore	Karnataka
India	S.P. Medical College & A. G. of Hospitals	Bikaner	Rajashthan
India	Post Graduate Institute of Medical Education and Research	Chandigarh
India	Choithram Hospital & Research Centre	Indore	Madhya Pradesh
India	Patel Hospital Pvt. Ltd.	Jalandhar	Punjab
India	Chatrapati Sahuji Mahraj Medical University	Lucknow	Uttar Pradesh
India	Christian Medical College, Ludhiana	Ludhiana	Punjab
India	Kasturba Hospital,	Manipal	Karnataka
India	V.M. Medical College & Safdarjang Hospital	New Delhi	Delhi
India	Seth G.S. Medical College & KEM Hospital	Parel	Mumbai
India	Rajiv Gandhi Cancer Institute & Research Center	Rohini	Delhi
India	Lokmanya Tilak Municipal Medical College & General Hospital	Sion	Mumbai
India	Regional Cancer Centre	Trivandrum	Kerala
India	Christian Medical College	Vellore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Pharnmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Survival time		12 months	No
Primary	Time to Tumor Progression		12 Months	No
Secondary	hematological toxicity, PSA levels, Quality of Life		12 months	Yes