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Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Neoplasms

Intervention: Mitoxantrone (Drug); GM-CSF (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Dr. Sandy Srinivas, Principal Investigator, Affiliation: Stanford University


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.

Clinical Details

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

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

Primary outcome: 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)

Secondary outcome:

PSA response, defined as the first evidence of a total serum PSA decline of >50% from baseline maintained for at least 28 days and confirmed with two consecutive measurements taken two weeks apart

Time to sustained biochemical response, defined as the time from first administration of drug to first evidence of sustained response

Duration of sustained response, defined as time from PSA decrease of >50% from baseline to the first evidence of disease progression

Detailed description: 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 HRPC.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.


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 chemotherapy)

- 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

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Starting date: July 2006
Last updated: July 3, 2012

Page last updated: August 23, 2015

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