TroVax® In Subjects With Hormone Refractory Prostate Cancer (HRPC)

NCT01194960 | Terminated Phase 2

• 1 other identifier: TV2/001/09
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses, thus leading to a more effective therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression free survival (PFS) of subjects with HRPC.

Conditions

Hormone Refractory Prostate Cancer

Keywords

cancer of prostate; cancer of the prostate; neoplasms prostate; neoplasms prostatic; prostate cancer; prostate neoplasms; prostatic cancer; prostate specific antigen; prostatic hyperplasia

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  To establish whether the incidence of progression-free survival (as defined by the absence of progression assessed by both RECIST and PCWG2 criteria) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.

  Week 37

Secondary Outcomes (1)

• Clinical progression-free survival

  37 weeks

Study Arms (2)

Docetaxel Alone

ACTIVE COMPARATOR

Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.

Drug: Docetaxel

TroVax plus Docetaxel

EXPERIMENTAL

Subjects will receive both TroVax plus 10 cycles of Docetaxel.

Drug: Docetaxel; Drug: TroVax

Interventions

Docetaxel DRUG

Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.

Docetaxel Alone; TroVax plus Docetaxel

TroVax DRUG

Trovax on Days 1,10, 22 and then Weeks 7, 10, 13, 19, 25, 31 and 37

TroVax plus Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed \& dated written informed consent obtained from subject in accordance w/local regulations.
• Histologically confirmed conventional and/or mucinous adenocarcinoma of the prostate. If histological confirmation is not available, cytological confirmation will be permitted in lieu.
• Must meet one of following 3 criteria for progressive disease following androgen deprivation:
• A. Subjects w/nodal or visceral metastases:
• Must have progressive disease defined by RECIST criteria or defined by the Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008).
• B. Subjects w/no measurable disease:
• PSA only disease must have an elevated PSA as defined by Consensus Criteria Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008). PSA must indicate progressive disease defined as rising PSA values, at least 7 days apart, \>2 ng/mL in the 28 days prior to randomization.
• C. Subjects w/bone involvement:
• New disease on bone scan as defined by Consensus Criteria Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008). 4. Subjects on stable dose of bisphosphonates showing subsequent tumor progression may continue on this medication; however, subjects are not allowed to initiate bisphosphonate therapy w/in 28 days prior to starting study treatment at Week 1 or at any time after that during the study, 5. Must be clinically immunocompetent. Clinical immunocompetence assumed unless subject has been diagnosed as immunosuppressed, is receiving immunosuppressive chemotherapy for oncology disorders, or is receiving immunosuppressive therapy following transplant, in which case they will be excluded.
• \. Subject free of clinically apparent/active autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's Disease, Hashimoto's Thyroiditis, Multiple Sclerosis, \& Rheumatoid Arthritis).
• \. Subject has adequate bone marrow function defined by Absolute Lymphocyte Count (ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) \>1200/µL, Platelet Count \>100,000/µL.
• \. Subject has peripheral neuropathy grade ≤1. 9. Subject has ECOG status of 0 or 1. 10. Minimum life expectancy ≥6 months. 11. Progressive disease (as defined above) must be documented after discontinuation of the hormonal and anti-androgen therapy.
• \. Subject continues to stay on medical treatment such as LHRH agonists or LHRH antagonists to maintain testosterone value of \<50ng/dL.

You may not qualify if:

• Subject has received prior chemotherapy for prostate cancer at any time. Subject has received chemotherapy for any other reason within five years of screening.
• Subject is receiving any other hormonal therapy, including any dose of Megestrol Acetate, Finasteride, any herbal product known to decrease PSA levels (e.g., Saw Palmetto \& PC-SPES), or any systemic corticosteroid must discontinue agent for at least 4 weeks prior to the anticipated Week 1 visit. LHRH agonists or LHRH antagonists do not need to be discontinued.
• Subject has started bisphosphonate or denosumab therapy less than 28 days before the anticipated Week 1 visit.
• Conventional multivitamin supplements
• Selenium
• Lycopene
• Soy supplements
• Vitamin E
• Fish oil supplements
• Vitamin D
• Glucosamine supplements
• Age-related eye disease vitamins
• Ginkgo biloba
• Subject has had major surgery or radiation therapy completed \<4 weeks prior to screening.
• Corticosteroids are not permitted except for (a) nasal sprays and inhalers, (b) orally prescribed as replacement therapy in the case of adrenal insufficiency, (c) oral or IV dexamethasone administration used acutely in combination with docetaxel, (d) parenteral use on a single occasion, (e) low dose parenteral use for a maximum of 5 days and (f) acute and sporadic parenteral use for acute asthma.

Sponsors & Collaborators

• Oxford BioMedica: lead
• MedSource LLC: collaborator

Study Sites (7)

San Bernardino Urology

San Bernardino, California, 92404, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

GU Research Network

Omaha, Nebraska, 68130, United States

Location

New York University Cancer Institute

New York, New York, 10016, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Charleston Hematology Oncology Associates

Charleston, South Carolina, 29403, United States

Location

Related Publications (1)

• Harrop R, Chu F, Gabrail N, Srinivas S, Blount D, Ferrari A. Vaccination of castration-resistant prostate cancer patients with TroVax (MVA-5T4) in combination with docetaxel: a randomized phase II trial. Cancer Immunol Immunother. 2013 Sep;62(9):1511-20. doi: 10.1007/s00262-013-1457-z. Epub 2013 Jul 23.

  PMID: 23877659 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

Docetaxel; TroVax

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Anna C. Ferrari, MD

  New York University Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (7)