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

This study is currently recruiting participants.
Verified by Stanford University, September 2008

Sponsors and Collaborators: Stanford University
Bayer
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00477087
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: Mitoxantrone
Drug: GM-CSF
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Mitoxantrone hydrochloride    Mitoxantrone    Sargramostim    Granulocyte-macrophage colony-stimulating factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 Measures:
  • 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
  • Overall survival

Estimated Enrollment:   20
Study Start Date:   July 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

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 study
  • Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477087

Locations
United States, California
Stanford University School of Medicine     Recruiting
      Stanford, California, United States, 94305
      Contact: Denise Haas, MBA     650-736-1252     dhaas@stanford.edu    
      Contact: Cancer Clinical Trials Office     (650) 498-7061        
      Principal Investigator: Dr. Sandy Srinivas            
      Sub-Investigator: Natalia Colocci            

Sponsors and Collaborators
Stanford University
Bayer

Investigators
Principal Investigator:     Dr. Sandy Srinivas     Stanford University    
  More Information


Study ID Numbers:   PROS0017, 96817, NCT00477087, PROS0017
First Received:   May 18, 2007
Last Updated:   October 3, 2008
ClinicalTrials.gov Identifier:   NCT00477087
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Mitoxantrone
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Sensory System Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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