Pilot Study of DRibble Vaccine for Prostate Cancer Patients

NCT02234921 | Completed Phase 1

• 1 other identifier: 14-116B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.

Conditions

Adenocarcinoma of the Prostate

Keywords

Prostate; Adenocarcinoma; Metastatic; DRibble; Immunotherapy; Microbiome

Outcome Measures

Primary Outcomes (1)

• Safety Assessment

  Patients will come to clinic 10 times over a 28 week period and have blood tests and vital sign measurements at each visit. In addition, patients will have 8 physical exams and performance status evaluations during this time period to evaluate possible toxicities related to study treatment.

  28 Weeks

Secondary Outcomes (2)

• Immune Response

  28 weeks

• Prostate Cancer Response to DRibble vaccine

  28 weeks

Other Outcomes (1)

• Microbiome identification

  12 weeks

Study Arms (1)

DRibble Vaccine

EXPERIMENTAL

Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).

Drug: Cyclophosphamide; Biological: DRibble Vaccine; Biological: HPV Vaccinations; Drug: Imiquimod

Interventions

Cyclophosphamide DRUG

A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.

Also known as: Cytoxan

DRibble Vaccine

DRibble Vaccine BIOLOGICAL

DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.

Also known as: DPV-001 DRibble vaccine

DRibble Vaccine

HPV Vaccinations BIOLOGICAL

Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.

Also known as: Ceravix

DRibble Vaccine

Imiquimod DRUG

Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.

DRibble Vaccine

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have measurable or evaluable metastatic castrate resistant adenocarcinoma of the prostate with progression after chemotherapy, combined androgen blockade and/or peripheral androgen or androgen receptor suppression. Either histologic or serum marker diagnosis is acceptable.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Ability to give informed consent and comply with the protocol.
• Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
• Patients must have normal organ and marrow function as determined by routine blood tests

You may not qualify if:

• Active autoimmune disease except vitiligo or hypothyroidism.
• Active other malignancy.
• Known HIV positive and/or Hepatitis B or C positive.
• Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.

Sponsors & Collaborators

• UbiVac: lead
• Providence Health & Services: collaborator
• Providence Cancer Center: collaborator
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator

Study Sites (1)

Providence Health & Services

Portland, Oregon, 97213, United States

Location

Related Links

• Providence Cancer Center

MeSH Terms

Conditions

Adenocarcinoma; Neoplasm Metastasis; Sialorrhea

Interventions

Cyclophosphamide; Imiquimod

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Brendan Curti, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: October 24, 2014
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)