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Home > "A" Clinical Trials Conditions > APC8015 and Bevacizumab in Treating Patients With Prostate Cancer  APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,stage 2 prostate cancer,stage 3 prostate cancer,stage 1 prostate cancer
Status: No longer recruiting
Sponsor(s): University of California, San Francisco , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as APC8015 use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with biological therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating patients who have undergone radiation therapy and/or surgery and who have progressive prostate cancer.
Details: OBJECTIVES: - Determine the efficacy of APC8015 (Provenge) and bevacizumab in patients with progressive prostate cancer. - Determine any immune response in patients treated with this regimen. - Determine the safety of this regimen in these patients. OUTLINE: Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity. Patients are followed every month. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 11 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - T1-3, N0-1, M0 - Received prior therapy for primary prostate cancer comprising external beam radiotherapy, brachytherapy with or without pelvic external beam radiotherapy, or radical prostatectomy with or without adjuvant or salvage radiotherapy - PSA less than 1.0 ng/mL after radiotherapy OR less than 0.4 mg/mL after radical prostatectomy - PSA no greater than 6.0 ng/mL after radical prostatectomy with adjuvant or salvage radiotherapy AND at least 3 months since androgen deprivation - Elevated PSA (0.4-6.0 ng/mL) that has increased on 2 measurements taken at least 1 week apart - No gross local recurrence or metastatic disease other than PSA elevation - 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: Age: - Not specified 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 malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or other adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for prostate cancer Chemotherapy: - No prior chemotherapy for prostate cancer Endocrine therapy: - See Disease Characteristics - 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: - See Disease Characteristics - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery, including open biopsy or needle biopsy of liver - No prior cryosurgery as only definitive therapy of primary tumor - 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 prior experimental agents for prostate cancer - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricSmall, Study Chair, University of California, San Francisco
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Additional Information:
Study ID Numbers: CDR0000069047; UCSF-0155-01,NCI-2617,UCSF-01554
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027599
Other Adenocarcinoma Of The Prostate Studies:
1. Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer
2. Neoadjuvant Thalidomide in Treating Patients With Locally Advanced Prostate Cancer Who Are Undergoing Radical Prostatectomy
3. Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
4. Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
5. Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
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