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A Randomized, Phase II Trial of Brief Androgen-Ablation Combined With Cell-Based CG1940/CG8711 Immunotherapy For Prostate Cancer in Patients With Non-Metastatic, Biochemically Relapsed Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Randomized, Phase II Trial of Brief Androgen-Ablation Combined With Cell-Based CG1940/CG8711 Immunotherapy For Prostate Cancer in Patients With Non-Metastatic, Biochemically Relapsed Prostate Cancer



- To determine the median PSA recurrence-free survival of patients with nonmetastatic,
biochemically relapsed prostate cancer who respond with a PSA ≤ 0.5 ng/mL when
administered a brief (6-month) course of androgen ablation either alone or in
combination with GVAX prostate cancer vaccine (CG1940/CG8711) immunotherapy.


- To determine the safety of combined treatment with androgen ablation and CG1940/CG8711
immunotherapy in these patients.

- To determine median time to metastatic disease development in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (>
7 vs ≤ 7), PSA doubling time (< 3 months vs 3-9 months vs > 9 months) and prior androgen
ablation (yes vs no). Patients are randomized to 1 of 2 treatment arms at a 1 (arm I):2 (arm
II) ratio.

- Arm I (androgen-ablation therapy): Patients receive oral bicalutamide once daily on
days 1-28. Patients also receive luteinizing hormone-releasing hormone (LHRH) agonist
treatment comprising leuprolide acetate or goserelin intramuscularly (IM) on day 8.
Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.

- Arm II (androgen-ablation therapy and vaccine): Patients receive androgen ablation as
in arm I. Patients also receive GVAX prostate cancer vaccine (CG1940 and CG8711)
intradermally (ID) on day 1. Beginning on day 1 of week 3, patients receive booster
doses of CG1940 and CG8711 ID every 2 weeks for 24 weeks.

Patients are evaluated on day 1 of week 25 to assess disease. If PSA > 0.5 ng/mL AND there
is no evidence of metastatic disease on imaging studies, then patients can be treated at the
discretion of the investigator. If PSA ≤ 0.5 ng/mL, and there is no evidence of metastatic
disease, then patients are considered responders and continue having PSA evaluated every 4
weeks until PSA relapse.

After completion of study therapy, patients are followed periodically for 5 years and then
annually thereafter.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Biochemically relapsed prostate cancer

- Must have received primary therapy (i.e., radical prostatectomy, definitive
radiotherapy, brachytherapy, or cryotherapy)

- If patient has a rising PSA after radical prostatectomy, salvage radiotherapy
must have been offered

- Evidence of biochemical progression as determined by 3 PSA measurements, each higher
than the previous value and meeting the following criteria:

- The second PSA (PSA2) must be obtained at least 8 weeks after the first (PSA1)

- The third PSA (PSA3) must be obtained at least 2 weeks after the PSA2 and within
the past 4 weeks

- The PSA3 must be > 2.0 ng/mL and ≤ 20 ng/mL

- Must not have received more than 1 course of prior androgen ablation, defined as
treatment with a luteinizing hormone-releasing hormone agonist resulting in a
castrate testosterone level AND a PSA nadir ≤ 0.1 followed by subsequent withdrawal
of androgen ablation and recovery of testosterone to a non-castrate level

- No evidence of metastatic disease on radionuclide bone scan and CT scan performed
within the past 8 weeks

- Retroperitoneal lymphadenectomy ≤ 2 cm is not considered metastatic for purposes
of this study


- ECOG performance status 0-1

- WBC > 2,500/mm³

- ANC ≥ 1,500/mm³

- Hemoglobin > 9.0 g/dL

- Platelet count ≥ 100,000/mm³

- Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN

- PT/INR ≤ 1.3

- Serum testosterone normal

- Fertile patients must use effective contraception

- No active autoimmune disease or history of autoimmune disease requiring treatment
with systemic immunosuppression including, but not limited to, any of the following:

- Inflammatory bowel disease

- Systemic lupus erythematosus

- Systemic vasculitis

- Scleroderma

- Multiple sclerosis

- Hemolytic anemia

- Sjögren syndrome

- Sarcoidosis

- No known active infection

- No uncontrolled concurrent illness including, but not limited to, any of the

- Systemic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to leuprolide acetate, bicalutamide, or sargramostim (GM-CSF)

- No known sensitivity to materials of bovine origin

- No hypersensitivity to GM-CSF or to any of the other components of CG1940/CG8711,
which includes fetal bovine serum, dimethyl sulfoxide (DMSO), and hydroxyethyl starch
and may include small amounts of porcine trypsin and DNase


- See Disease Characteristics

- More than 4 weeks since prior and no concurrent systemic corticosteroids

- Use of inhaled corticosteroids for asthma or chronic obstructive pulmonary
disease (COPD) is permitted

- More than 4 weeks since prior and no concurrent chemotherapy or other cancer therapy

- More than 4 weeks since prior and no concurrent use of herbal products (e.g., saw
palmetto or PC-SPES)

- At least 4 weeks since prior and no other concurrent investigational agents

- No other concurrent anticancer commercial agents or therapies

- Prior androgen ablation administered concomitantly with primary radiotherapy allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median PSA recurrence-free survival in patients in patients responding to the study treatments

Safety Issue:


Principal Investigator

Charles G. Drake, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center



Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage I prostate cancer
  • Prostatic Neoplasms