GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

NeuroTherapia, Inc.

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Procedure: conventional surgery; Drug: thalidomide; Procedure: neoadjuvant therapy; Biological: sargramostim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00400517

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CCF-4643 (Other Identifier)

BRLX-CASE-CCF-4643 (Other Identifier)

CELGENE-CASE-CCF-4643 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

GM-CSF Injections and Oral Thalidomide

Experimental group

Description:

taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.

Treatment:

Biological: sargramostim

Procedure: conventional surgery

Procedure: neoadjuvant therapy

Drug: thalidomide