GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere

NCT00274287 | Completed Phase 2 Results

• 1 other identifier: 0412
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression (TTP)

  The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported

  up to 21 months

Secondary Outcomes (4)

• Response Rate (PSA)

  up to 21 months

• Response Rate (Radiographic)

  up to 21 months

• Median Overall Survival (OS)

  up to 44 months

• Median Number of GM-CSF Cycles

  up to 12 months

Study Arms (1)

GM-CSF

EXPERIMENTAL

Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol

Drug: GM CSF

Interventions

GM CSF DRUG

250 ug/m2 daily for 2 weeks followed by 2 weeks of rest

Also known as: Leukine

GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men \>18 years of age. No upper age limit
• Written informed consent approved by institutional review board should be explained to and signed by patient
• Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this study.
• Metastatic disease as evidenced by visceral involvement, bone disease, or PSA elevation.
• Patients should meet the criteria of androgen independent prostate cancer (AIPC). Patients would fulfill these criteria if they continue to progress despite complete androgen blockade (surgical or medical castration with anti-androgen) and despite an anti-androgen withdrawal trial. Failing anti-androgen withdrawal is defined as no decline by 25% or more 3-weeks after stopping anti-androgens.
• Progression on hormonal therapy is defined as ANY of the following:
• PSA: 2 consecutive rising PSA values, at least 14-days apart, each being \> 5 ng/ml
• For patients with visceral measurable disease, progression is defined as an increase by 50% or more in the size of measurable areas, or any development of new lesions.
• For patients with bone-only disease, progression is defined as the appearance of 2 or more new areas of abnormal uptake on a bone scan, when compared to prior imaging studies. Changes in the uptake of already existing lesions will NOT be used to define progressive disease.
• For patients with bone AND visceral disease, fulfilling any of the criteria in 5.2 or 5.3 is sufficient to define progression.
• Castration levels of testosterone (\< 50 ng/dl) achieved via medical or surgical castration. Patients should continue on LHRH agonists throughout if this is the method used to achieve castration.
• Life expectancy of at least 6 months
• Adequate hematologic, renal, and liver function as evidenced by the following:
• WBC \> 2000,
• ANC \> 1000,

You may not qualify if:

• presence of brain metastases
• Known HIV+ status
• ECOG performance status of 2 or higher
• Use of investigational agents within 4 weeks of starting
• Any medical intervention or other condition which, in the opinion of the principle investigator, could compromise adherence with study requirements.

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

Related Publications (1)

• Nabhan C, Meyer A, Tolzien K, Bitran JD, Lestingi TM. A phase II pilot trial investigating the efficacy and activity of single agent granulocyte macrophage colony-stimulating factor as maintenance approach in castration - resistant prostate cancer patients responding to chemotherapy. Avicenna J Med. 2011 Jul;1(1):12-7. doi: 10.4103/2231-0770.83718.

  PMID: 23210004 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Colony-Stimulating Factors; sargramostim

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)

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: Chadi Nabhan, MD
• Organization: Oncology Specialists, S.C.

cnabhan@oncmed.net

847-268-8200

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: 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: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 10, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 28, 2019
• Results First Posted: May 9, 2012

Record last verified: 2019-03

Locations

US (1)