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Study of Trovax® Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer

This study has been terminated.
(Oxford BioMedica halted TroVax injections)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521274
First Posted: August 27, 2007
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oxford BioMedica
Information provided by (Responsible Party):
The Methodist Hospital System
  Purpose
The purpose of this study is to evaluate the role of combination therapy with Trovax plus Docetaxel or Docetaxel alone in patients with prostate cancer with a rising prostate specific antigen (PSA).

Condition Intervention Phase
Prostatic Neoplasms Biological: MVA 5T4 Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Assess the Activity of MVA 5T4 (Trovax®) Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer (HRPC)

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Time to PSA progression Safety: To compare adverse events, laboratory measurements and vital sign measurements between the treatment groups [ Time Frame: PSA measured every 6 weeks ]

Secondary Outcome Measures:
  • PSA response rate Tumor response Overall survival [ Time Frame: PSA and tumor response measured every 6 weeks ]

Enrollment: 11
Study Start Date: August 2007
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Patients randomized to Arm 1 will receive treatment cycles of Docetaxel and vaccine.

PI relocated, data not available.

Biological: MVA 5T4
Docetaxel will be administered at the completion of the first three TroVax® injections. Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients will receive up to 10 total Docetaxel infusions over the course of the study. Subsequent TroVax® injections will be delivered on Day 1 of each Docetaxel cycle, 2 hours prior to the chemotherapy administration.
Other Name: TroVax
Active Comparator: 2

Patients randomized to Arm 2 will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over).

PI relocated, data not available.

Drug: Docetaxel
Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). Patients will receive up to 10 total Docetaxel infusions over the course of the study. If patients cross-over, TroVax® will be administered 2 hours prior to the chemotherapy administration.
Other Name: Taxotere

Detailed Description:

Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer.

Trovax is vaccine that targets 5T4 receptors on tumor cells. 5T4 has been detected in the majority of primary prostate cancers. Based on 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 therapeutic approach for patients with metastatic androgen independent prostate cancer (AIPC).

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • Progressive disease after androgen deprivation.
  • ECOG Status < 2.
  • No prior chemotherapy for prostate cancer therapy
  • 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.
  • Clinically immunocompetent.
  • Free of clinically apparent/active autoimmune disease
  • Absolute Lymphocyte Count ≥ 500/µl, ANC >1200/µl, Platelet count >100,000/µl, Hemoglobin > 10 mg/dl, Peripheral neuropathy <1.
  • No evidence of active ischemia on ECG
  • Age greater 18 years

Exclusion Criteria:

  • Patients who have received prior chemotherapy.
  • 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, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements, Vitamin E
  • Patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment
  • 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 more than 5 years previously and have no known evidence of residual or recurrent disease
  • Serious intercurrent infections or nonmalignant medical illnesses which are uncontrolled.
  • Psychiatric illnesses/social situations that would limit compliance with protocol requirements.
  • AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. The bilirubin must be within normal limits.
  • Renal function creatinine ≥1.5 x ULN.
  • Known allergy to egg proteins.
  • Known allergy to neomycin.
  • History of allergic response to previous vaccinia vaccinations.
  • Chronic oral corticosteroid use (especially anti-emetics) unless prescribed as replacement therapy in the case of adrenal insufficiency.
  • Known to test positive for HIV or hepatitis B or C - testing prior to study not required.
  • Clinical indication of reduced cardiac function or an ejection fraction of ≤ 40%.
  • Requirement for radiotherapy (this is a sign of disease progression and is classed as a withdrawal criterion).
  • Concurrent chemotherapy, immunotherapy and radiation therapy
  • No investigational or commercial agents or therapies other than those included in protocol treatment may be administered with the intent to treat the patient's malignancy.
  • Prior exposure to TroVax®.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521274


Locations
United States, Texas
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Oxford BioMedica
Investigators
Principal Investigator: Robert J Amato, DO Baylor College of Medicine - Methodist Hospital
  More Information

Additional Information:
Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT00521274     History of Changes
Other Study ID Numbers: HMRI IRB#0407-0036
PCa-07-101 ( Other Identifier: Principal Investigator )
First Submitted: August 23, 2007
First Posted: August 27, 2007
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Methodist Hospital System:
Progressive Hormone Refractory Prostate Cancer
HRPC
MVA 5T4
Trovax®
Docetaxel
M3thodist

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs