Trial Outcomes & Findings for GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer (NCT NCT00400517)

NCT ID: NCT00400517

Last Updated: 2018-08-28

Results Overview

Pathologic Complete Response is defined as complete eradication of tumor.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-08-28

Participant Flow

Participant milestones

Measure	GM-CSF Injections and Oral Thalidomide taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	GM-CSF Injections and Oral Thalidomide taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

Baseline characteristics by cohort

Measure	GM-CSF Injections and Oral Thalidomide n=27 Participants taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Pathologic Complete Response is defined as complete eradication of tumor.

Outcome measures

Measure

GM-CSF Injections and Oral Thalidomide n=26 Participants taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy

Proportion of Patients P0 at Surgery

0 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.

Outcome measures

Measure

GM-CSF Injections and Oral Thalidomide n=26 Participants taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy

Proportion of Patients With Negative Surgical Margins

0 Participants

PRIMARY outcome

Timeframe: 8 weeks

Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.

Outcome measures

Measure

GM-CSF Injections and Oral Thalidomide n=27 Participants taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy

Prostate-specific Antigen Response

22 Participants

PRIMARY outcome

Timeframe: 32 months

Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.

Outcome measures

Measure

GM-CSF Injections and Oral Thalidomide n=26 Participants taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy

Time to Clinical Progression

5 Participants

Adverse Events

GM-CSF Injections and Oral Thalidomide

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	GM-CSF Injections and Oral Thalidomide n=27 participants at risk taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy
Skin and subcutaneous tissue disorders Injection Site Reaction	3.7% 1/27
Skin and subcutaneous tissue disorders Urticaria	3.7% 1/27
Blood and lymphatic system disorders Thrombocytopenia	3.7% 1/27

Other adverse events

Measure	GM-CSF Injections and Oral Thalidomide n=27 participants at risk taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. sargramostim: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day thalidomide: doses up to 400 mg/day conventional surgery: SOC care surgery neoadjuvant therapy: post radical prostatectomy
Gastrointestinal disorders Constipation	63.0% 17/27
Skin and subcutaneous tissue disorders Injection Site Reaction	55.6% 15/27
Nervous system disorders Peripheral Neropathy	25.9% 7/27
General disorders Fatigue	44.4% 12/27
General disorders Solmnolene/Dizziness	33.3% 9/27

Additional Information

Dr. Jorge Garcia

Cleveland Clinic

Phone: 2164447774

Email: Garciaj4@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place