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

NCT00448409 | Completed Phase 2

• 2 other identifiers: HMRI IRB#0106-0009TV/PHRPC-001/06
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer; hormone refractory prostate cancer; androgen resistant prostate cancer

Outcome Measures

Primary Outcomes (4)

• PSA response rate to TroVax® and TroVax® in combination with GM-CSF

  restaging every 8 weeks

• Anti-5T4 antibody levels

  1st 2 cycles every 2 wks; thereafter about every 4 wks

• CD8+ve cellular response to 5T4 antigen as measured by Elispot

  at end of study

• Assessment of the number of adverse events and serious adverse events in both groups

  AEs as occur

Secondary Outcomes (4)

• Objective response rate

  restaging every 8 weeks

• Overall survival of the patients

  restaging every 8 weeks

• Progression-free survival

  restaging every 8 weeks

• Time to progression

  restaging every 8 weeks

Study Arms (2)

1

EXPERIMENTAL

TroVax alone

Biological: TroVax

2

EXPERIMENTAL

TroVax plus GM-CSF

Biological: TroVax; Drug: GM-CSF

Interventions

TroVax BIOLOGICAL

11 Intramuscular injection of TroVax® over 45 weeks. A single dose of 5 x 108 pfu/ml, will be given by an intramuscular injection into the deltoid muscle of the upper arm.

1; 2

GM-CSF DRUG

168 subcutaneous GM-CSF injections over 45 weeks. Administered every day as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) in weeks 1 and 2 of each 28 day cycle (total of 14 days per cycle with a total of 12 cycles).

Also known as: Leukine

2

Eligibility Criteria

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

You may qualify if:

• 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
• No evidence of active ischemia on ECG

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Oxford BioMedica: collaborator

Study Sites (1)

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

TroVax; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim

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)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Robert J Amato, DO

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 16, 2007
• Study Start: May 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2007
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)