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

NCT ID: NCT00274287

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-12-31

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.

Detailed Description

Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression was documented the patients were taken off study.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GM-CSF

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

Group Type: EXPERIMENTAL

GM CSF

Intervention Type: DRUG

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

Interventions

GM CSF

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

Intervention Type: DRUG

Other Intervention Names

Leukine

Eligibility Criteria

Inclusion Criteria

1. Men >18 years of age. No upper age limit

2. Written informed consent approved by institutional review board should be explained to and signed by patient

3. Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this study.

4. Metastatic disease as evidenced by visceral involvement, bone disease, or PSA elevation.

5. 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.

6. 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.

7. Life expectancy of at least 6 months

8. Adequate hematologic, renal, and liver function as evidenced by the following:

• WBC > 2000,
• ANC > 1000,
• Platelet count > 100,000,
• HgB > 9.0 g/dl, Creatinine < 2,
• Total bilirubin < 2x upper limit of normal,
• AST and ALT < 3 x upper limit of normal

9. ECOG performance status of 0 or 1.

10. The use of intravenous polyphosphates for bone metastases is allowed.

11. upon completion of the taxotere portion of study, patient can be enrolled & receive GM-CSF if ANY of the following criteria is met:

• Patients received total of 8 cycles of taxotere & have no signs of disease progression
• Patients achieved their maximal response despite receiving < than 8 cycles of taxotere. Maximum response is defined as a drop in measures of PSA by 10% or less on 2 consecutive measurements.
• Patients who have completed their chemotherapy < than 12 weeks prior to opening this trial & still have stable disease without progression (by PSA and radiographically) will be eligible to receive maintenance GM-CSF

Exclusion Criteria

1. presence of brain metastases

2. Known HIV+ status

3. ECOG performance status of 2 or higher

4. Use of investigational agents within 4 weeks of starting

8. Any medical intervention or other condition which, in the opinion of the principle investigator, could compromise adherence with study requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Oncology Specialists, S.C.

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sigrun Hallmeyer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chadi Nabhan, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology Specialists, SC

Locations

Oncology Specialists, SC

Park Ridge, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23210004 (View on PubMed)

Other Identifiers

0412

Identifier Type: -

Identifier Source: org_study_id

NCT00336037

Identifier Type: -

Identifier Source: nct_alias