Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Prostatic Neoplasms

Mycobacterium Infections

Communicable Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Docetaxel

Immunomodulating Agents

Adjuvants, Immunologic

Tubulin Modulators

Antimitotic Agents

Mycobacterium w.

Sudhir Rawal, MD

Arup Kumar Mandal, MD

Devakar Dalela, MD

N K Mohanty, M.D.

Jayesh Dhabalia, MD

Arun Chawla, MD

Sujata Patwardhan, MD

P G Jayaprakash, MD

Amil Lal Bhat, MD

Raju T Chacko, MD

Sushil Bhatia, MD

Kim Mammen, MD

K C Lakshmaiah, MD

Rajeev Gupta, MD

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.

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.

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

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

Cadila Pharnmaceuticals

Rare Diseases

Recurrence

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

BCG Vaccine

Vaccines

Immunologic Factors

Mycobacterium w

BCG (Bacillus Calmette-Guerin)

Mahesh Desai, MD

N K Mohanty, MD

Amillal Bhat, MD

B. R. Srivastav, MD

Jitendra Amlani, MD

Anup Kundu, MD

H. K. Moorthy, MD

Shrawan K. Singh, MD

Purshottam K. Puri, MD

Rajeev Sood, MD

Padmaraj Hegde, MD

Yathish Kumar, MD

The purpose of this study is to determine and compare the effect of this treatment on recurrence rate and to assess the toxicity in both arms of patients with STCC. Other objectives include determining the effects of this treatment on quality of life, and comparing the effect of Mycobacterium w on time to tumor progression.

Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder

Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial to Compare the Efficacy and Toxicity of Mycobacterium w Intra-dermal to Intravesical BCG in Patients With Newly Diagnosed Superficial Transitional Cell Carcinoma With High Probability of Recurrence

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Two intradermal treatments each week for first 4 weeks followed by one intradermal treatment per week for second 4 weeks.

CADI-05

Paul J Mosca, M.D., Ph.D.

This study examines the safety of treating patients with advanced stage melanoma with the vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune response will be collected.

Because there are no highly effective treatment options for patients with advanced, unresectable melanoma, participation in clinical trials of novel therapies is frequently the best therapeutic alternative. CADI-05 is a promising agent for two reasons. First, patients with advanced melanoma frequently have disturbing symptoms such as anorexia with associated weight loss, fatigue, and chemotherapy-associated side effects such as nausea and vomiting. CADI-05 not only has a very low side effect profile, but it actually improves such symptoms. Second, melanomas are generally immunogenic, and sometimes patients mount significant of immune responses to cause spontaneous regression of tumors. High-dose interleukin-2, a relatively toxic therapy that stimulates the immune system, causes long-term regression in stage IV melanoma in a small percentage of patients. In addition, when combined with adoptive immunotherapy, response rates as high as 50% have been observed. Therefore, induction of potent antitumor immune responses in melanoma can be a highly effective therapeutic modality. Because CADI-05 has potent immunostimulatory effects and an excellent side effect profile, it is a very attractive option for treatment of stage IV melanoma patients. Preliminary data from ongoing preclinical studies in a murine melanoma model have shown that CADI-05 has significant biological activity in metastatic melanoma (G. Robertson, unpublished data).

Although it is possible that CADI-05 as a single agent will have activity in advanced melanoma, it may also be useful in conjunction with other systemic agents or as an adjuvant in conjunction with immunotherapy regimens. In addition, previous human trials suggest that CADI-05 may be helpful in symptom control and improvement of quality of life in patients with advanced melanoma. In spite of the promising data from a number of preclinical and clinical studies of this agent, no U.S. studies of the effects of CADI-05 in cancer patients have been performed. Therefore, the present research study proposes to evaluate the safety of CADI-05 treatment in advanced melanoma. In addition, preliminary data regarding the clinical response rate and immune response will be collected.

Safety Study of CADI-05 in Patients With Advanced Stage Melanoma

Open Label, Single Arm, Phase I/II Study of CADI-05 in Patients With Advanced Stage III or Stage IV Melanoma

Dr. Bakulesh M. Khamar, Director of Research

All enrolled patients to receive Mycobacterium w

Ketan Rajyaguru, MD

Gaurang Gandhi, MD

Kapil Thakkar, MD

B. R. Shrivastav, MD

Rasesh Desai, MD

N. K. Mohanty, MD

Ketan Shukla, MD

Krishna Moorhty, MD

The primary purpose of this study is to evaluate the response rate of this treatment (Mw) in patients with BCG refractory superficial transitional cell carcinoma. Other objectives include detecting the effect of Mw on Time to Tumor progression and evaluating safety.

Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder

Open Label, Single Arm, Exploratory Phase I Clinical Trial to Evaluate Efficacy and Safety of Mycobacterium w (Mw) in BCG Refractory Superficial Transitional Cell Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer	NCT00525408	Hormone Refract...	Mycobacterium w... Docetaxel	18 Years -	Cadila Pharnmaceuticals
Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder	NCT00694915	Bladder Cancer	Mycobacterium w BCG (Bacillus C...	18 Years -	Cadila Pharnmaceuticals
Safety Study of CADI-05 in Patients With Advanced Stage Melanoma	NCT00675727	Stage III or St...	CADI-05	18 Years -	Cadila Pharnmaceuticals
Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder	NCT00694915	Bladder Cancer	Mycobacterium w BCG (Bacillus C...	18 Years -	Cadila Pharnmaceuticals
A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer	NCT00525408	Hormone Refract...	Mycobacterium w... Docetaxel	18 Years -	Cadila Pharnmaceuticals
Study of Mycobacterium w in BCG Refractory Superficial Transitional Cell Carcinoma of Bladder	NCT00694798	Bladder Cancer	Mycobacterium w	18 Years -	Cadila Pharnmaceuticals

Spots Global Cancer Trial Database for mycobacterium w