A Phase II Study Of Prostatic Acid Phosphatase-Pulsed Dendritic Cells (Provenge) In Combination With Bevacizumab In Patients With Serologic Progression Of Prostate Cancer After Definitive Local Therapy
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Any T, any N, M0
- Received prior therapy comprising one of the following regimens for primary prostate
cancer:
- External beam radiotherapy
- Brachytherapy with or without pelvic external beam radiotherapy
- Cryosurgery
- Radical prostatectomy with or without adjuvant or salvage radiotherapy
- Adjuvant or salvage radiotherapy after radical prostatectomy is allowed
provided the following criteria is met:
- PSA was never greater than 6.0 ng/mL
- At least 3 months since androgen deprivation
- Elevated PSA (0.4-6.0 ng/mL) that has increased on 2 measurements taken at least 2
weeks apart
- No history of or radiological evidence of current CNS disease (e.g., primary brain
tumor, seizures not controlled with standard medical therapy, or brain metastases)
PATIENT CHARACTERISTICS:
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 months
Hematopoietic:
- WBC greater than 2,500/mm^3
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- No prior bleeding disorder
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 2 times ULN
- Hepatitis B and C negative
Renal:
- Creatinine no greater than 2 times ULN
- BUN no greater than 2 times ULN
Cardiovascular:
- No clinically significant cardiovascular disease
- No New York Heart Association grade II-IV heart disease (symptomatic congestive heart
failure)
- No unstable angina pectoris
- No serious cardiac arrhythmia requiring medication
- No uncontrolled hypertension
- No prior myocardial infarction
- No grade II or greater peripheral vascular disease within the past year
- No prior deep vein thrombosis
Other:
- Fertile patients must use effective contraception
- HIV and HTLV I and II negative
- No other uncontrolled illness, underlying medical condition, psychiatric illness, or
social situation that would preclude study participation
- No ongoing or active infection
- No active autoimmune disease requiring treatment
- No significant traumatic injury within the past 4 weeks
- No serious nonhealing wound, ulcer, or bone fracture
- No other "currently active" malignancy except nonmelanoma skin cancer
- Not "currently active" if considered by physician as having less than 30% risk
of relapse after completion of therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No prior anti-vascular endothelial growth factor therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone [LHRH]
agonists or antagonists, antiandrogens, estrogens, megestrol, or PC-SPES) for
progressive disease
- Prior hormonal therapy in adjuvant or neoadjuvant setting as primary therapy allowed
if at least 3 months since androgen deprivation
- No concurrent systemic steroid therapy (inhaled or topical steroids allowed)
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- At least 4 weeks since prior major surgery, including open biopsy or needle biopsy of
liver
- No concurrent major surgery
Other:
- At least 10 days since prior aspirin
- At least 10 days since prior oral or parenteral anticoagulants except to maintain
patency of pre-existing permanent indwelling IV catheters
- No concurrent aspirin
- No concurrent oral or parenteral anticoagulants except to maintain patency of
pre-existing permanent indwelling IV catheters
- No other concurrent experimental or commercial agents or therapies for prostate
cancer