Clinical trial NCT00400517: GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
Official title: Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage III prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate
stage I prostate cancer
stage IV prostate cancer
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-17
Enrollment: 28
Sex: MALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: OBJECTIVES:

* 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.

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

Primary outcomes:
measure: Proportion of Patients P0 at Surgery
timeFrame: 8 weeks
measure: Proportion of Patients With Negative Surgical Margins
timeFrame: 8 Weeks
measure: Prostate-specific Antigen Response
timeFrame: 8 weeks
measure: Time to Clinical Progression
timeFrame: 32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jorge Garcia, MD, FACP
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Eric Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: