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

NCT00477087 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-0473896817PROS0017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Assessed as the time from the 1st dose of study drug to death or 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)

  18 months

Secondary Outcomes (2)

• Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)

  18 months

• Overall Survival (OS)

  18 months

Study Arms (1)

GM-CSF Plus Mitoxantrone

EXPERIMENTAL

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.

Drug: Mitoxantrone; Drug: GM-CSF

Interventions

Mitoxantrone DRUG

Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic.

Also known as: Novantrone

GM-CSF Plus Mitoxantrone

GM-CSF DRUG

GM-CSF is a biologic response modifier, classified as a colony stimulating factor.

Also known as: Sargramostim, Leukine, Granulocyte-Macrophage Colony Stimulating Factor

GM-CSF Plus Mitoxantrone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: males (prostate cancer)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Bayer: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Mitoxantrone; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Sandy Srinivas, MD; Professor of Medicine (Oncology)
• Organization: Stanford University Medical Center

sandysri@stanford.edu

650-725-2078

Study Officials

• Dr. Sandy Srinivas

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: July 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 29, 2017
• Results First Posted: November 29, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)