GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: sargramostim; thalidomide; conventional surgery; neoadjuvant therapy
Intervention description: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day; doses up to 400 mg/day; SOC care surgery; post radical prostatectomy
Intervention MeSH terms: Thalidomide; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage III prostate cancer; stage II prostate cancer; adenocarcinoma of the prostate; stage I prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different
      ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by
      blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the
      tumor smaller and reduce the amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide
      works in treating patients undergoing surgery for high-risk prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

          -  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

        PRIOR CONCURRENT THERAPY:

          -  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