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A Randomized, Double-Blind Phase II Study of Sipuleucel-T (Provenge®) Followed by Indoximod or Placebo in the Treatment of Patients With Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Castration Resistant Prostate Cancer

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Trial Information

A Randomized, Double-Blind Phase II Study of Sipuleucel-T (Provenge®) Followed by Indoximod or Placebo in the Treatment of Patients With Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate Cancer

Sipuleucel-T will be administered as standard of care. Oral Indoximod/placebo will be
self-administered twice daily for 6 months starting after the last infusion of sipuleucel-T.
Patients will be treated for a minimum of 12 weeks of Indoximod/placebo before disease
progression can be declared and Indoximod/placebo will not be discontinued for increasing
prostate specific antigen (PSA) in the absence of symptomatic clinical progression.

Inclusion Criteria:

- Histologically documented adenocarcinoma of the prostate with metastatic disease as
evidenced by soft tissue and/or bony metastases on baseline computed tomography (CT)
scan of the abdomen and pelvis and/or bone scan

- Castration-resistant based on a current or historical evidence of disease progression
despite surgical or medical castration as demonstrated by one or more of the

- PSA progression (defined as two consecutive prostate specific antigen (PSA)
measurements at least 14 days apart ≥ 2.0 ng/ml and ≥ 50% above the minimum PSA
during castration therapy or above pre-treatment value if no response)

- progression of measurable disease based on Response Evaluation Criteria In Solid
Tumors (RECIST) criteria (≥ 50% increase in the sum of the cross products of all
measurable lesions or the development of any new lesions

- progression of non-measureable disease

- Serum PSA ≥ 2.0 ng/ml at study enrollment

- Castration levels of testosterone defined as ≤ 30 ng/dL at study enrollment. Must be
at least 3 months from surgical castration or must have received medical castration
therapy for at least 3 months and be receiving such therapy at the time of confirmed
disease progression

- Asymptomatic or minimally symptomatic disease as demonstrated by Eastern Cooperative
Oncology Group (ECOG) Performance Status 0 or 1 and no need for opiate pain
medications to control pain/symptoms

- Age 18 years and old

- Adequate bone marrow, renal and hepatic function within 14 days of study enrollment
defined as:

- Bone marrow: WBC > 3,000/uL; absolute neutrophil count > 1,500/uL; platelets >

- Renal: creatinine within institutional upper limit of normal (ULN) OR creatinine
clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above ULN

- Hepatic: total bilirubin < 1.5 X institutional ULN; aspartate aminotransferase
(AST ((SGOT)) and alanine aminotransferase (ALT((SGPT)) < 2.5 X institutional

Exclusion Criteria:

- Chronic steroid dependence (should stop all steroid supplementation 4 weeks prior to

- Human immunodeficiency virus (HIV)-positive patients and those with other
acquired/inherited immunodeficiency

- History of gastrointestinal disease causing malabsorption or obstruction such as, but
not limited to Crohn's disease, celiac sprue, tropical sprue, bacterial
overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions,
achalasia, bowel obstruction, or extensive small bowel resection

- Inability to take medications by mouth

- History of allergic reactions attributed to compounds of similar chemical or biologic

- Active autoimmune disease, chronic inflammatory condition, conditions requiring
concurrent use of any systemic immunosuppressants or steroids. Mild-intermittent
asthma requiring only occasional beta-agonist inhaler use or mild localized eczema
will not be excluded.

- Previous allo-transplant of any kind

- History of prior treatment with anti-CTLA4 blocking antibody

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Immune Response to Sipuleucel-T

Outcome Description:

Assess the augmentation of immune response to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo.

Outcome Time Frame:

14 Weeks from First Leukapheresis

Safety Issue:


Principal Investigator

Gautam Jha, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

July 2015

Related Keywords:

  • Metastatic Castration Resistant Prostate Cancer
  • hormone refractory prostate cancer
  • Prostatic Neoplasms



Moffitt Cancer Center Tampa, Florida  33612
Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455
Mayo Clinic - Rochester Rochester, Minnesota  55905
Georgia Health Sciences, University Augusta, Georgia  30912
VA Medical Center, University of Nebraska Omaha, Nebraska  68198