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Activity of TroVax® Alone vs. TroVax® Plus GM-CSF in Patients With Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Activity of TroVax® Alone vs. TroVax® Plus GM-CSF in Patients With Prostate Cancer

A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) in Patients With Progressive Hormone Refractory Prostate Cancer

NCT00448409•The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of Trovax and GM-CSF in patients with prostate cancer.

Detailed Description

Prostate cancer is the second leading cause of cancer death in American men. Hormonal ablation, in the form of medical or surgical castration is the cornerstone of management for metastatic prostate cancer however, treatment options for a patient in whom androgen ablation fails are limited. Second-line hormonal agents are generally associated with low response rates and no documented survival benefit. Historically, chemotherapy was not considered to have significant activity in hormone refractory prostate cancer (HRPCa). This view has changed within the past 10 years, partly because of the availability of prostate-specific antigen (PSA) measurements to monitor tumor burden. Although it seems that chemotherapy, either as a single agent or combination of agents may lead to clinical responses, reduction in PSA measurements, pain control, or improved quality of life, no benefit in overall survival has been definitively proven. The current standard of care for the treatment of metastatic prostate cancer is hormone therapy (androgen blockade).3,4 When this strategy is no longer effective, few good treatment options are left. For this reason, prostate cancer research has aimed to identify new therapeutic modalities to increase the impact of these parameters as well as prolong patient survival. A total of 24 men with prostate cancer ranging from non-metastatic rising PSA only disease to bony metastatic disease will be enrolled in the study. All patients will have failed androgen treatment and at least one prior taxane chemotherapy or have refused chemotherapy. Out of the 24 patients, 12 patients will be treated using TroVax® and 12 will be treated using TroVax® plus GM-CSF.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed adenocarcinoma of the prostate.
•Stable or progressive disease after androgen deprivation.
•Karnofsky Performance Status ≥ 60%.
•At least one prior taxane based chemotherapy for prostate cancer therapy (or patient refusal of chemotherapy)
•At least four weeks have lapsed since prior chemotherapy (if administered)
•Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
•Major surgery or radiation therapy completed ≥ 4 weeks prior to enrollment.
•Clinically immunocompetent. All patients are assumed to be immunocompetent unless they have been diagnosed as being immunosuppressed, are receiving oral steroids, immunosuppressive chemotherapy for oncology disorders or are receiving immunosuppressive therapy following transplant.
•Free of clinically apparent autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).
•Absolute Lymphocyte Count ≥ 500/µl, ANC \>1200/µl, Platelet count \>100,000/µl, Hemoglobin \> 8 mg/dl
+1 more criteria

Exclusion Criteria

•Patients receiving any other hormonal therapy, including any dose of megestrolacetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. Progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy.
•Patients that initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
•No supplements or complementary medicines/botanicals are permitted during the study
•Major surgery or radiation therapy completed ≤ 4 weeks prior to enrollment.
•Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
•"Currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse.
•Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.
•Psychiatric illnesses/social situations that would limit compliance with protocol requirements.
•Liver function tests (ALT, AST) more than 1.5 x upper limit of normal (ULN). The bilirubin must be within normal limits.
•Renal function creatinine ≥1.5 x ULN.
+9 more criteria

Locations (1)

The Methodist Hospital Research Institute

Houston, Texas, United States

Key Dates

Start Date

May 1, 2006

Primary Completion Date

April 1, 2007

Completion Date

May 1, 2007

Last Updated

March 17, 2016

Enrollment

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

TroVax

BIOLOGICAL

GM-CSF

DRUG

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07225946

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITING

Prostate Active Surveillance Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Activity of TroVax® Alone vs. TroVax® Plus GM-CSF in Patients With Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Prostate Active Surveillance Study

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

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