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

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Drug: Mitoxantrone; Drug: GM-CSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00477087

96817 (Other Identifier)

IRB-04738

PROS0017 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.

Full description

This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent

• Age ≥ 18 years

• Histologically-confirmed adenocarcinoma of the prostate

• Hormone-refractory prostate cancer

• Failed 1st-line docetaxel-containing regimen

• No prior immunotherapy including:

  • Vaccines
  • GM-CSF

• Minimum prostate-specific antigen (PSA) > 5 mg/dL and rising according to the PSA Consensus Criteria

• Karnofsky Performance Status (KPS) > 60%

• Eastern Cooperative Oncology Group (ECOG) Performance Status < 3

• Life expectancy > 6 months

Exclusion criteria

• Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist

• 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

• Any nonmalignant medical illness

• Absolute neutrophil count (ANC) < 1,500/µL

• Platelet count < 100,000 µL

• Hemoglobin < 8 mg/dL

• Total bilirubin greater than 1.5 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN if no demonstrable liver metastases, or greater than 5.0 x ULN in presence of liver metastases

• Ejection fraction < 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan

• Noncompliance with study procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

GM-CSF Plus Mitoxantrone

Experimental group

Description:

GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.

Treatment:

Drug: GM-CSF

Drug: Mitoxantrone