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A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Docetaxel, PSK®
Docetaxel, Placebo
Sponsored by
Bastyr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostate, Neoplasm, Adenocarcinoma, Cancer, Metastatic, Castrate resistant, Docetaxel, PSK, Krestin, Trametes versicolor, Safety, Maximum tolerated dose, Mushroom, Natural, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients 18 years or older
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Evidence of metastatic disease by standard imaging studies (bone scan, Computerized Tomography Scan (CT) or Magnetic Resonance Imaging (MRI))
  • Testosterone levels <50 ng/dL

  • Confirmed progressive disease defined by one or more of the following:

    • an increase in PSA, > 2ng/dL x 2 or more values at least 1 week apart in the setting of metastatic disease
    • appearance of new bone lesions on bone scan
    • progression of soft tissue lesion defined by the Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 criteria
  • Concurrent use of an agent for testosterone suppression (e.g., Luteinizing Hormone Releasing Hormone [LHRH] agonist) if the patient is not surgically castrate
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 determined within 28 days before enrollment
  • Recovery to CTCAE grade ≤ 1 toxicity, to patient's baseline status (except alopecia), or toxicities deemed irreversible from the effects of prior cancer therapy (CTCAEs grade > 1 that are not considered a safety risk by the investigator will be allowed)

  • Adequate bone marrow function defined as:

    • absolute neutrophil count (ANC) > 1500 cells/mm³ without growth factor support
    • platelet count > 100,000 cells/mm³ without transfusion or growth factor support
    • hemoglobin > 9g/dL without transfusion or growth factor support

  • Adequate liver function defined as:

    • total bilirubin < upper limit of normal (ULN)
    • alanine aminotransferase (ALT) < 1.5 x ULN
    • aspartate aminotransferase (AST) < 1.5 x ULN
  • Adequate renal function defined as serum creatinine level within normal limits (WNL)
  • At least a 6-month or greater life expectancy
  • Ability to understand and sign a written informed consent, which will be obtained from study participants before undergoing any study-specific procedures
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
  • Suitable venous access for the study-required blood sampling (i.e., including PK sampling)

Exclusion Criteria:

  • Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic disease
  • Prior adjuvant or neo-adjuvant chemotherapy within 12 months of study entry
  • Last dose of sipuleucel-T therapy within 4 weeks of enrollment
  • Any investigational therapies within 4 weeks of study entry
  • Radiotherapy within 4 weeks of study entry
  • Major surgery within 4 weeks of study entry, and not fully recovered to baseline or a stable clinical status
  • Uncontrolled high blood pressure (systolic blood pressure > 160mmHg, diastolic blood pressure > 95mmHg)
  • Receiving chronic steroid therapy. Topical and inhaled steroids are permitted
  • Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80, or to mushroom products
  • Any comorbid condition or unresolved toxicity that would preclude administration of docetaxel
  • Medical contraindication to any docetaxel pre-medications
  • History of > grade 2 neurotoxicity or any toxicity from any cause that has not resolved to < grade 1
  • Brain or other CNS metastasis
  • The need for chronic daily immunosuppressive therapy, including concurrent use of prednisone
  • Evidence of active second malignancy, except non-melanoma skin cancer
  • Infection requiring intravenous antibiotic therapy or other severe infection within 14 days preceding first dose of study drug
  • Inability to swallow oral medication or maintain a fast, as required 2 hours before and 1 hour after PSK administration
  • Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction
  • Other medical or psychiatric condition that may increase the risk associated with trial participation or any other condition in the judgment of the investigator that may interfere with the interpretation of trial results or would make the patient inappropriate for enrollment in this trial

Sites / Locations

  • Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Docetaxel, PSK®

Docetaxel, Placebo

Arm Description

A 21-day lead-in oral PSK alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 evey 3 weeks for three cycles. After the third dose of docetaxel, study drug will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered.

A 21-day lead-in oral placebo alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. After the third dose of docetaxel, the placebo will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered.

Outcomes

Primary Outcome Measures

Determine tolerability dose of PSK alone and in combination with docetaxel
Adverse events are graded to determine a dose limiting toxicity of PSK during the lead-in PSK alone and during the docetaxel treatment in combination with PSK.
Determine maximum tolerated dose and recommended phase 2 dose of PSK in combination with docetaxel
When the maximum tolerated dose is determined, a total of 15 patients will be treated with the recommended phase 2 dose with the combination of docetaxel chemotherapy.

Secondary Outcome Measures

Pharmacokinetics of docetaxel when combined with oral PSK
The plasma docetaxel levels are analyzed at eight time points during the cycle 1 of standard intravenous docetaxel at 75 mg/m2 with oral PSK/Placebo. After the seven-day washout of PSK/placebo at the cycle 3, the plasma docetaxel levels are analyzed again at eight time points during the cycle 4 of docetaxel treatment without PSK/Placebo.
Pharmacokinetics of oral PSK dosing and in combination with docetaxel
The serum PSK levels are analyzed at two time points during the lead-in cycle and eight time points during the cycle 1 of standard intravenous docetaxel at 75 mg/m2 with oral PSK/Placebo. After the seven-day washout of PSK/placebo at the cycle 3, the plasma docetaxel levels are analyzed again at eight time points during the cycle 4 of docetaxel treatment without PSK/Placebo.
Immunological laboratory analysis
Natural Killer (NK) cell functional activity, distributions of NK, B, and T cells, and IFN-gamma and TNF-alpha production capacity are analyzed and compared to those of the placebo group.
Clinical tumor markers
Circulating tumor cell (CTC) and prostate specific antigen (PSA) levels are compared to that of the placebo group during the oral PSK lead-in period and during the combination therapy with docetaxel and PSK.
Prostatic acid phosphatase
The serum level of prostatic acid phosphatase levels are compared to that of the placebo group during the oral PSK lead-in period and during the combination therapy with docetaxel and PSK.

Full Information

First Posted
September 6, 2012
Last Updated
October 23, 2015
Sponsor
Bastyr University
Collaborators
University of Washington, Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01685489
Brief Title
A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
Official Title
A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
funding sequestered
Study Start Date
May 2013 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bastyr University
Collaborators
University of Washington, Fred Hutchinson Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4 (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of PSK/placebo lead-in and during cycles 1 and 4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostate, Neoplasm, Adenocarcinoma, Cancer, Metastatic, Castrate resistant, Docetaxel, PSK, Krestin, Trametes versicolor, Safety, Maximum tolerated dose, Mushroom, Natural, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel, PSK®
Arm Type
Experimental
Arm Description
A 21-day lead-in oral PSK alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 evey 3 weeks for three cycles. After the third dose of docetaxel, study drug will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered.
Arm Title
Docetaxel, Placebo
Arm Type
Placebo Comparator
Arm Description
A 21-day lead-in oral placebo alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. After the third dose of docetaxel, the placebo will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered.
Intervention Type
Drug
Intervention Name(s)
Docetaxel, PSK®
Other Intervention Name(s)
Polysaccharide-K, Krestin, Polysaccharide-Kureha
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Placebo
Primary Outcome Measure Information:
Title
Determine tolerability dose of PSK alone and in combination with docetaxel
Description
Adverse events are graded to determine a dose limiting toxicity of PSK during the lead-in PSK alone and during the docetaxel treatment in combination with PSK.
Time Frame
42 days
Title
Determine maximum tolerated dose and recommended phase 2 dose of PSK in combination with docetaxel
Description
When the maximum tolerated dose is determined, a total of 15 patients will be treated with the recommended phase 2 dose with the combination of docetaxel chemotherapy.
Time Frame
106 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics of docetaxel when combined with oral PSK
Description
The plasma docetaxel levels are analyzed at eight time points during the cycle 1 of standard intravenous docetaxel at 75 mg/m2 with oral PSK/Placebo. After the seven-day washout of PSK/placebo at the cycle 3, the plasma docetaxel levels are analyzed again at eight time points during the cycle 4 of docetaxel treatment without PSK/Placebo.
Time Frame
106 days
Title
Pharmacokinetics of oral PSK dosing and in combination with docetaxel
Description
The serum PSK levels are analyzed at two time points during the lead-in cycle and eight time points during the cycle 1 of standard intravenous docetaxel at 75 mg/m2 with oral PSK/Placebo. After the seven-day washout of PSK/placebo at the cycle 3, the plasma docetaxel levels are analyzed again at eight time points during the cycle 4 of docetaxel treatment without PSK/Placebo.
Time Frame
106 days
Title
Immunological laboratory analysis
Description
Natural Killer (NK) cell functional activity, distributions of NK, B, and T cells, and IFN-gamma and TNF-alpha production capacity are analyzed and compared to those of the placebo group.
Time Frame
106 days
Title
Clinical tumor markers
Description
Circulating tumor cell (CTC) and prostate specific antigen (PSA) levels are compared to that of the placebo group during the oral PSK lead-in period and during the combination therapy with docetaxel and PSK.
Time Frame
106 days
Title
Prostatic acid phosphatase
Description
The serum level of prostatic acid phosphatase levels are compared to that of the placebo group during the oral PSK lead-in period and during the combination therapy with docetaxel and PSK.
Time Frame
106

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients 18 years or older Histologically confirmed diagnosis of adenocarcinoma of the prostate Evidence of metastatic disease by standard imaging studies (bone scan, Computerized Tomography Scan (CT) or Magnetic Resonance Imaging (MRI)) Testosterone levels <50 ng/dL Confirmed progressive disease defined by one or more of the following: an increase in PSA, > 2ng/dL x 2 or more values at least 1 week apart in the setting of metastatic disease appearance of new bone lesions on bone scan progression of soft tissue lesion defined by the Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 criteria Concurrent use of an agent for testosterone suppression (e.g., Luteinizing Hormone Releasing Hormone [LHRH] agonist) if the patient is not surgically castrate Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 determined within 28 days before enrollment Recovery to CTCAE grade ≤ 1 toxicity, to patient's baseline status (except alopecia), or toxicities deemed irreversible from the effects of prior cancer therapy (CTCAEs grade > 1 that are not considered a safety risk by the investigator will be allowed) Adequate bone marrow function defined as: absolute neutrophil count (ANC) > 1500 cells/mm³ without growth factor support platelet count > 100,000 cells/mm³ without transfusion or growth factor support hemoglobin > 9g/dL without transfusion or growth factor support Adequate liver function defined as: total bilirubin < upper limit of normal (ULN) alanine aminotransferase (ALT) < 1.5 x ULN aspartate aminotransferase (AST) < 1.5 x ULN Adequate renal function defined as serum creatinine level within normal limits (WNL) At least a 6-month or greater life expectancy Ability to understand and sign a written informed consent, which will be obtained from study participants before undergoing any study-specific procedures Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures Suitable venous access for the study-required blood sampling (i.e., including PK sampling) Exclusion Criteria: Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic disease Prior adjuvant or neo-adjuvant chemotherapy within 12 months of study entry Last dose of sipuleucel-T therapy within 4 weeks of enrollment Any investigational therapies within 4 weeks of study entry Radiotherapy within 4 weeks of study entry Major surgery within 4 weeks of study entry, and not fully recovered to baseline or a stable clinical status Uncontrolled high blood pressure (systolic blood pressure > 160mmHg, diastolic blood pressure > 95mmHg) Receiving chronic steroid therapy. Topical and inhaled steroids are permitted Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80, or to mushroom products Any comorbid condition or unresolved toxicity that would preclude administration of docetaxel Medical contraindication to any docetaxel pre-medications History of > grade 2 neurotoxicity or any toxicity from any cause that has not resolved to < grade 1 Brain or other CNS metastasis The need for chronic daily immunosuppressive therapy, including concurrent use of prednisone Evidence of active second malignancy, except non-melanoma skin cancer Infection requiring intravenous antibiotic therapy or other severe infection within 14 days preceding first dose of study drug Inability to swallow oral medication or maintain a fast, as required 2 hours before and 1 hour after PSK administration Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction Other medical or psychiatric condition that may increase the risk associated with trial participation or any other condition in the judgment of the investigator that may interfere with the interpretation of trial results or would make the patient inappropriate for enrollment in this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celestia Higano, MD
Organizational Affiliation
Seattle Cancer Care Alliance - University of Washington
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cynthia A Wenner, Ph.D
Organizational Affiliation
Bastyr University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leanna J Standish, PhD, ND, LAc
Organizational Affiliation
Bastyr University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary (Nora) L Disis, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

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Links:
URL
http://www.bastyr.edu
Description
General information of Bastyr University

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A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer

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