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Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy

Phase 2
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy


- Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic
response (histologic P0, margin positivity, capsular penetration), prostate-specific
antigen (PSA) response, and other investigational endpoints in patients with high-risk
prostate cancer undergoing prostatectomy.

- Determine the safety and feasibility of GM-CSF and thalidomide.

OUTLINE: This is an open-label study.

Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral
thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses
in the absence of unacceptable toxicity.

Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate meeting any of the following
criteria for high-risk disease:

- Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific
antigen [PSA])

- Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)

- Serum PSA ≥ 10 ng/dL (any grade or stage)

- Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5
years based on Kattan's nomogram

- No clinical evidence of CNS metastases

- No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan,
x-ray) within 8 weeks of study entry

- Appropriate medical candidate for radical prostatectomy


- ECOG performance status 0-1

- Creatinine ≤ 2.0 mg/dL

- Granulocyte count ≥ 1,800/mm³

- Platelet count ≥ 100,000/mm³

- AST < 3 times upper limit of normal

- Bilirubin ≤ 1.5 mg/dL

- Fertile patients must use effective contraception during and for 4 weeks after
completion of study treatment

- No active unresolved infection

- No pre-existing peripheral neuropathy > grade 1

- No known HIV positivity

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of
the bladder

- No known contraindication to sargramostim (GM-CSF) or thalidomide


- No prior radiotherapy to the prostate or pelvis

- No prior chemotherapy or hormonal therapy for prostate cancer

- No parenteral antibiotics within the past 7 days

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients P0 at surgery

Safety Issue:


Principal Investigator

Robert Dreicer, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

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



Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065