Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hypoglycemic Agents

Androgens

Rosiglitazone

Given orally twice daily. Participants may continue study treatment as long as their disease does not progress and they don't experience any serious side effects.

Placebo

Matthew Smith, MD

The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate specific antigen (PSA) levels.

* Patients will be randomly assigned to initial treatment with either rosiglitazone or placebo orally twice daily, every day as long as there is no disease progression or serious side effects. Patients will be asked to complete a drug log to keep track of the medication.
* Before treatment begins the following tests will be performed: physical exam; bone scan; blood work (including PSA level test) and a urine sample.
* While on this study the following tests and procedures will be done once a month: review of side effects and routine blood tests (including PSA levels).
* While on this study the following tests and procedures will be done on months 2 and 4: review of side effects; routine blood tests (including PSA levels) and urine tests.
* If the patient's disease progressed the treatment code will be broken and if the patient was on placebo, they will have the option to begin taking rosiglitazone.

Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer

Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study

Dana-Farber Cancer Institute

Massachusetts General Hospital

Professor of Medicine

Symptoms and General Pathology

Infections

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Mycoses

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Sezary Syndrome

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Antineoplastic Agents

Bexarotene

rosiglitazone added to bexarotene capsules

Rosiglitazone and Bexarotene

John A Zic, MD

The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL.

Treatment options for CTCL include both skin-directed and systemic therapies. Topical treatments are effective for early-stage disease that is localized to the skin. However, disease involving the lymph nodes or visceral sites can be palliated but rarely cured, even with the most aggressive regimens of systemic chemotherapy. Unfortunately, current treatment options at this stage only provide a short term response. Thus, it is important that additional therapies are investigated to manage this malignancy.

Bexarotene has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL).Bexarotene binds the RXR(Retinoid X Receptor)inside the cell, a receptor that forms heterodimers with a multitude of other nuclear receptors. One of these is the PPARγ (Peroxisome Proliferator Activator Receptor Gamma), a nuclear receptor that binds Rosiglitazone.Rosiglitazone is an FDA approved antidiabetic agent of the Thiazolidinedione class. Rosiglitazone increases insulin sensitivity and is useful in the treatment of type 2 diabetes. In vitro data suggest that rosiglitazone and bexarotene may act synergistically to induce apoptosis in cell lines derived from patients with cutaneous T cell lymphoma (CTCL). This pilot study will investigate this possible synergism in a small cohort of patients with stable or progressive CTCL already being treated with bexarotene.

Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

Open Label Pilot Study of Combination Therapy With Rosiglitazone and Bexarotene to Investigate a Possible Synergism in the Treatment of Cutaneous T-Cell Lymphoma

mSWAT scoring. Range 0 to 400. Measured every 4 weeks.

FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best

10-cm visual analog scale, 10= worst, 1=best

Vanderbilt University

Associate Professor of Medicine/Dermatology

All enrolled patients received rosiglitazone in addition to oral bexarotene.

All enrolled patients received rosiglitazone in addition to oral bexarotene

Single Arm Study

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

John Zic, MD

All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.

Number of Participants With a 50% Improvement in Baseline Skin Score

Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.

Quality of Life Evaluations

Pruritus Score

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer	NCT00182052	Adenocarcinoma ... Prostate Cancer	Rosiglitazone Placebo	18 Years -	Massachusetts General Hospital
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL	NCT00178841	Cutaneous T-cel... Mycosis Fungoid... Sezary Syndrome	Rosiglitazone a...	18 Years -	Vanderbilt University

Spots Global Cancer Trial Database for avandia

Every month we try and update this database with for avandia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for avandia

Every month we try and update this database with for avandia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for avandia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.