Know Cancer

forgot password

Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Prostatic Neoplasms

Thank you

Trial Information

Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer

The purpose of this study is to evaluate the effect of the combination of mitoxantrone and
GM-CSF on time to progression in patients with hormone-refractory prostate cancer. To date,
there are no curative treatments for prostate cancer that has become hormone-refractory.
Treatments appropriate for prostate cancer at this stage include docetaxel, which, in
combination with prednisone, has recently been shown to lead to a survival benefit, and
mitoxantrone, which, to date, has been shown to lead to a more favorable outcome than
steroids alone, but without a survival benefit. GM-CSF is a cytokine that is thought to lead
to an enhanced antitumor immune response, presumably through induction of tumor necrosis
factor and interleukin-1 expression, as well as growth and proliferation of macrophages and
dendritic cells. Both preclinical models and Phase II studies have suggested that GM-CSF as
a single agent may have antitumor activity in advanced prostate cancer. To date, the use of
GM-CSF for the treatment of prostate cancer has been explored in different contexts, and,
more specifically, as a single agent in androgen-independent prostate cancer (AIPC) and
hormone-refractory prostate cancer (HRPC), in combination with thalidomide in hormone-naïve
prostate cancer and androgen-dependent advanced prostate cancer with ketoconazole in AIPC,
and finally with CTLA4 in HRPC. For patients with HRPC who have failed first line
chemotherapy, few, non-curative options are available, one of them involving the use of
mitoxantrone. On the basis of GM-CSF's mechanism of action, the addition of GM-CSF to a
mitoxantrone-containing regimen may lead to enhanced antitumor activity in patients with

Inclusion Criteria:

- must give signed written informed consent

- must be of age 18 years or older

- must have histologically confirmed adenocarcinoma of the prostate

- must have hormone-refractory prostate cancer

- must have failed first-line docetaxel-containing regimen

- must not have had any prior immunotherapy including, but not limited to, vaccines
and GM-CSF

- minimum PSA > 5mg/dL, and rising according to the PSA Consensus Criteria (i.e.
progressive disease after androgen deprivation and during first-line docetaxel-based

- KPS > 60%

- Life expectancy of greater than 6 months

Exclusion Criteria:- Concomitant hormonal therapy

- Noncompliance

- Use of herbal products known to decrease PSA levels

- Use of supplements or complementary medicines, except for conventional multivitamin
supplements, selenium, lycopene, soy supplements, Vitamin E

- Initiation of bisphosphonates within one month prior to enrollment or throughout the

- Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to

- Major surgery or radiation therapy completed <4 weeks prior to enrollment

- Any concomitant second malignancy other than non-melanoma skin cancer

- Any concomitant serious infection or nonmalignant medical illness

- ANC < 1,500/µl, platelet count <100,000/µl, hemoglobin < 8 mg/dl

- Total bilirubin greater than 1.5 x ULRR

- ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater
than 5.0 x ULRR in presence of liver metastases

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression - 1st study drug dose to observation of disease progression (increase >25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of >20% KPS)

Outcome Time Frame:

2 consecutive measurements 2 weeks apart

Safety Issue:


Principal Investigator

Dr. Sandy Srinivas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

July 2006

Completion Date:

July 2010

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317