A study to evaluate the effect of immunoadjuvant therapy with Mycobacterium w and Docetaxel in Metastatic Hormone Refractory Prostate Cancer.

Phase 2

• Conditions: Malignant neoplasm of prostate, (2) ICD-10 Condition: C61||Malignant neoplasm of prostate,

• Registration Number: CTRI/2007/091/000033
• Lead Sponsor: Cadila Pharmaceuticals ltd

Brief Summary

This study will be an open label, multicentric, randomized, comparative controlled clinical trial. Patients assigned to test arm will receive Inj. Cyclophosphamide 300 mgm/m2 on day one. This will be followed by injection of Mycobacterium w on next day. Seven days following immunization Docetaxel will be administered by intravenous infusion on day 1 of a 21 days cycle for 6 cycles. Mycobacterium w will be given every 2nd & 3rd week of chemotherapy, and 30 days after last cycle subsequently for six months. Patients in control arm will receive only Docetaxel 75mg/m2 by intravenous infusion on day 1 of a 21 days cycle for 6 cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-29
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: Other
• Sex: Male
• Target Recruitment: 176

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 atleast 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 100,000 per cubic millimeter, §:A total bilirubin not greater 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Overall Survival	1. 12 months

Secondary Outcome Measures

Name	Time	Method
1. Quality of Life	2. PSA levels

Trial Locations

Locations (28)

Amrita Institute of Medical Sciences; 🇮🇳 Ernakulam, KERALA, India

Bhagwan Mahaveer Cancer Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Cancer Hospital & Research Centre; 🇮🇳 Gwalior, MADHYA PRADESH, India

Chhatrapati Shahuji Maharaj Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Choithram Hospital & Research Centre; 🇮🇳 Indore, MADHYA PRADESH, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Desai Urological Hospital; 🇮🇳 Vadodara, GUJARAT, India

Institute of Postgraduate Medical Education & Research; 🇮🇳 Kolkata, WEST BENGAL, India

Kasturba Medical College & Hospital; 🇮🇳 India

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Amrita Institute of Medical Sciences

🇮🇳Ernakulam, KERALA, India

Dr Georgie Mathew

Principal investigator

09895048261

georgiemathew@aims.amrita.edu