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

This study has been terminated.
Sponsor:
Collaborator:
MedSource
Information provided by (Responsible Party):
Oxford BioMedica
ClinicalTrials.gov Identifier:
NCT01194960
First received: September 2, 2010
Last updated: November 26, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Drug: Docetaxel
Drug: TroVax + Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study to Assess the Activity of TroVax® (MVA-5T4) Plus Docetaxel Versus Docetaxel Alone in Subjects With Progressive Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Oxford BioMedica:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Week 37 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical progression-free survival [ Time Frame: 37 weeks ] [ Designated as safety issue: No ]
    To establish whether the incidence of clinical progression-free survival (defined by the absence of progression assessed by RECIST criteria alone) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.


Enrollment: 25
Study Start Date: August 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel Alone
Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.
Drug: Docetaxel
Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.
Experimental: TroVax plus Docetaxel
Subjects will receive both TroVax plus 10 cycles of Docetaxel.
Drug: TroVax + Docetaxel
Subjects will receive both TroVax plus 10 cycles of Docetaxel.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Signed & dated written informed consent obtained from subject in accordance w/local regulations.
  2. Histologically confirmed conventional and/or mucinous adenocarcinoma of the prostate. If histological confirmation is not available, cytological confirmation will be permitted in lieu.
  3. 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.

6. 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).

7. 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.

8. 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.

12. Subject continues to stay on medical treatment such as LHRH agonists or LHRH antagonists to maintain testosterone value of <50ng/dL.

EXCLUSION CRITERIA:

  1. Subject has received prior chemotherapy for prostate cancer at any time. Subject has received chemotherapy for any other reason within five years of screening.
  2. 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.
  3. Subject has started bisphosphonate or denosumab therapy less than 28 days before the anticipated Week 1 visit.
  4. Subject is using supplements or complementary medicines/botanicals. Subjects should review label w/their doctor prior to enrolment. Exceptions to this exclusion:

    • Conventional multivitamin supplements
    • Selenium
    • Lycopene
    • Soy supplements
    • Vitamin E
    • Fish oil supplements
    • Vitamin D
    • Glucosamine supplements
    • Age-related eye disease vitamins
    • Ginkgo biloba
  5. Subject has had major surgery or radiation therapy completed <4 weeks prior to screening.
  6. 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.
  7. Subject is known to test positive for HIV or hepatitis B or C.
  8. Subject receiving concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents.
  9. Subject has Platelet count >400,000/μL; Monocytes >80,000/μL; Haemoglobin <11g/dL.
  10. Subject has cerebral metastases (known from previous investigations or clinically detectable).
  11. Subject has serum testosterone >50ng/dL.
  12. Subject has rheumatoid disease (asymptomatic subjects w/controlled & rarely flaring rheumatoid arthritis are also excluded).
  13. Subject exhibits evidence of symptomatic congestive heart failure, pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina, myocardial infarction or active ischemia on ECG. If an ECG taken prior to screening but within 28 days of the anticipated Week 1 visit is not available, an ECG must be performed at screening.
  14. Subject has uncontrolled severe hypertension >150/100mm Hg (if controlled w/medication this is not an exclusion).
  15. Subject is hypotensive.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194960

Locations
United States, California
San Bernardino Urology
San Bernardino, California, United States, 92404
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Nebraska
GU Research Network
Omaha, Nebraska, United States, 68130
United States, New York
New York University Cancer Institute
New York, New York, United States, 10016
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
United States, South Carolina
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Oxford BioMedica
MedSource
Investigators
Principal Investigator: Anna C. Ferrari, MD New York University Cancer Institute
  More Information

No publications provided

Responsible Party: Oxford BioMedica
ClinicalTrials.gov Identifier: NCT01194960     History of Changes
Other Study ID Numbers: TV2/001/09
Study First Received: September 2, 2010
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Oxford BioMedica:
cancer of prostate
cancer of the prostate
neoplasms prostate
neoplasms prostatic
prostate cancer
prostate neoplasms
prostatic cancer
prostate specific antigen
prostatic hyperplasia

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014