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A Phase II Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for the Treatment of Patients With Evidence of Serologic (PSA) Progression After Definitive Therapy for Localized Prostate Cancer


Phase 2
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase II Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for the Treatment of Patients With Evidence of Serologic (PSA) Progression After Definitive Therapy for Localized Prostate Cancer


Inclusion Criteria:



- Histologic diagnosis of adenocarcinoma of the prostate; stage T1-T3, N0-N1, M0

- Prior definitive therapy for primary prostate cancer consisting of:external beam
radiotherapy;brachytherapy with or without pelvic external beam radiation; or radical
prostatectomy with or without adjuvant or salvage radiation therapy

- Therapeutic PSA response to primary therapy below 1.0 ng/ml post radiation therapy or
below 0.4 ng/ml for radical prostatectomy

- Patients treated with adjuvant or salvage radiation therapy following radical
prostatectomy are eligible provided:Post prostatectomy PSA was never > 6.0 ng/ml,
last effective day of androgen deprivation is at least 3 months prior to study entry

- Recurrent PSA level elevation (between 0.4 ng/ml and 6.0 ng/ml) on two
determinations at least one week apart.

- No clinical evidence of gross local recurrence or known metastatic disease other than
PSA elevation. Transrectal ultrasound and/or biopsy to evaluate local recurrence is
not required. All patients will receive a bone scan and CT scan of the abdomen to
exclude metastases.

- Estimated life expectancy of at least 6 months.

- ECOG Performance status of 0 or 1.

- Willing and able to give informed consent.

Exclusion Criteria:

- Cryosurgery as definitive therapy of primary tumor.

- Any metastasis.

- No concurrent or prior malignancy is allowed except for the following: adequately
treated basal or squamous cell skin cancer, adequately treated Stage I or II cancer
from which the patient is currently in complete remission, or any other cancer from
which the patient has been disease-free for 5 years.

- Current systemic steroid therapy (inhaled or topical steroids acceptable).

- Prior hormonal therapy for treatment of progressive disease.

- Prior chemotherapy, immunotherapy, or therapy with other experimental agents for
prostate cancer.

- Any surgery within the prior 4 weeks.

- Bilirubin and SGOT > 2 x upper limit of normal.

- BUN and serum creatinine > 2.0 times normal.

- No active congestive heart failure.

- If there is a history of clinically significant obstructive airway disease, a DLCO
must exceed 50%.

- Active uncontrolled bacterial, viral or fungal infection until these conditions are
corrected or controlled.

- Any underlying medical condition which in the principal investigator's opinion will
make the administration of GM-CSF hazardous or obscure the interpretation of adverse
events.

- PSA > 6.0 ng/ml

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA Response

Outcome Time Frame:

Monthly

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

UCSF99551

NCT ID:

NCT00678054

Start Date:

April 1999

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115