Trial · NCT00477087

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

NCT00477087, Phase 2, Terminated, Stanford University; results first posted 2017-11-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer. Trials, record NCT00477087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00477087

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
NCT number: NCT00477087
Status: Terminated
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Stanford University
Conditions: Prostatic Neoplasms
Interventions: Mitoxantrone, GM-CSF
First posted: 2007-05-22
Last updated: 2017-11-29
Results first posted: 2017-11-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	18 months	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)
Secondary	Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)	18 months	Defined as the first evidence of a total serum PSA decline of \> 50% from baseline, maintained for at least 28 days, and confirmed with 2 consecutive measurements taken 2 weeks apart.
Secondary	Overall Survival (OS)	18 months	Assessed as the time from the 1st dose of study drug to death.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Progression-free Survival (PFS)	18 months	weeks	MEDIAN
SECONDARY	Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)	18 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival (OS)	18 months	Months	MEDIAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-free Survival (PFS)	GM-CSF Plus Mitoxantrone	7.5	Full Range 3 to 40	weeks
Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)	GM-CSF Plus Mitoxantrone	3		Participants
Overall Survival (OS)	GM-CSF Plus Mitoxantrone	7.8	Full Range 3 to 12.6	Months

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GM-CSF Plus Mitoxantrone	10
Overall Study	COMPLETED	GM-CSF Plus Mitoxantrone	10
Overall Study	NOT COMPLETED	GM-CSF Plus Mitoxantrone	0

Source ClinicalTrials.gov

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	GM-CSF Plus Mitoxantrone	6	10	6
other	Diarrhea	General disorders	GM-CSF Plus Mitoxantrone	1	10	1
other	Dizziness	Eye disorders	GM-CSF Plus Mitoxantrone	1	10	1
other	Heartburn	Gastrointestinal disorders	GM-CSF Plus Mitoxantrone	1	10	1
other	Chest pain	Cardiac disorders	GM-CSF Plus Mitoxantrone	1	10	1
other	Dyspnea	Infections and infestations	GM-CSF Plus Mitoxantrone	4	10	4
other	Nausea	Gastrointestinal disorders	GM-CSF Plus Mitoxantrone	2	10	2
other	Alopecia	Skin and subcutaneous tissue disorders	GM-CSF Plus Mitoxantrone	1	10	1
other	Vomiting	Gastrointestinal disorders	GM-CSF Plus Mitoxantrone	1	10	1
other	Night sweats	Nervous system disorders	GM-CSF Plus Mitoxantrone	3	10	3

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GM-CSF Plus Mitoxantrone
Total, other adverse events	GM-CSF Plus Mitoxantrone	10	10
Total, serious adverse events	GM-CSF Plus Mitoxantrone	4	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00477087

GET https://conductscience.org/api/trials/v1/NCT00477087/registered

API reference For AI assistants