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

NeuroTherapia, Inc. logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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