Clinical trial NCT00525408: A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hormone Refractory Prostate Cancer
Keywords: HRPC
Metastatic Hormone Refractory Prostate Cancer
Docetaxel
Mycobacterium w
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 134
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Median Survival time
timeFrame: 12 months
measure: Time to Tumor Progression
timeFrame: 12 Months
Secondary outcomes:
measure: hematological toxicity, PSA levels, Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: V.M. Medical College & Safdarjang Hospital
state: Delhi
city: Rohini
country: India
facility: Rajiv Gandhi Cancer Institute & Research Center
state: Delhi
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
state: Karnataka
city: Manipal
country: India
facility: Kasturba Hospital,
state: Karnataka
city: Trivandrum
country: India
facility: Regional Cancer Centre
state: Kerala
city: Indore
country: India
facility: Choithram Hospital & Research Centre
state: Madhya Pradesh
city: Parel
country: India
facility: Seth G.S. Medical College & KEM Hospital
state: Mumbai
city: Sion
country: India
facility: Lokmanya Tilak Municipal Medical College & General Hospital
state: Mumbai
city: Jalandhar
country: India
facility: Patel Hospital Pvt. Ltd.
state: Punjab
city: Ludhiana
country: India
facility: Christian Medical College, Ludhiana
state: Punjab
city: Bikaner
country: India
facility: S.P. Medical College & A. G. of Hospitals
state: Rajashthan
city: Vellore
country: India
facility: Christian Medical College
state: Tamil Nadu
city: Lucknow
country: India
facility: Chatrapati Sahuji Mahraj Medical University
state: Uttar Pradesh
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
affiliation: Rajiv Gandhi Cancer Institute
name: Sudhir Rawal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Arup Kumar Mandal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chatrapati Sahuji Mahraj Medical University
name: Devakar Dalela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Safdarjang Hospital
name: N K Mohanty, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SEth G S Medical College & KEM Hospital
name: Jayesh Dhabalia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasturba Medical College
name: Arun Chawla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LTMMC & LTMGH
name: Sujata Patwardhan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RCC, Trivandrum
name: P G Jayaprakash, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.P. Medical College & A.G. Hospitals
name: Amil Lal Bhat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian Medical College, Vellore, India
name: Raju T Chacko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Choithram Hospital & Research Centre
name: Sushil Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian Medical College, Ludhiana
name: Kim Mammen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kidwai Memorial Istitute of Oncology
name: K C Lakshmaiah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Patel Hospital Pvt. Ltd.
name: Rajeev Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: