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Phase II Randomized Study of Vaccine Containing Recombinant Vaccinia-Prostate-Specific Antigen (PSA) Admixed With rV-B7.1 Plus Recombinant Fowlpox-PSA Vaccine, Sargramostim (GM-CSF), and Interleukin-2 Versus Nilutamide Alone in Patients With Hormone-Refractory Prostate Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Related Publications Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Closed
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18 and over
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NCI
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NCI-00-C-0137 MB-NAVY-99-04, NCI-T99-0097, T99-0097, NCT00020254
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Objectives - Compare the difference in time to radiographic evidence of disease progression at 6 months in patients with hormone-refractory prostate cancer when treated with vaccine containing recombinant vaccinia-prostate-specific antigen (PSA) admixed with rV-B7.1 plus recombinant fowlpox-PSA vaccine, sargramostim (GM-CSF), and interleukin-2 vs nilutamide alone.
- Evaluate the vaccination therapy in relation to the change in T-cell precursor frequency and to the rise of serum PSA in this patient population.
Entry Criteria Disease Characteristics:
- Histologically confirmed hormone-refractory adenocarcinoma of the
prostate
- Rising PSA after orchiectomy and/or while receiving
at least 1 regimen of
luteinizing hormone-releasing hormone (LHRH)
- PSA must have risen at least 0.5 ng/mL from baseline on
2 successive
measurements during and/or after hormonal therapy
- PSA greater than 1.0 ng/mL
- If on antiandrogen therapy, must undergo antiandrogen
withdrawal for at least
6 weeks and still have evidence of rising PSA
- After prior bicalutamide, must undergo withdrawal for
at least 6 weeks and
still have evidence of rising PSA
- Testosterone no greater than 50 ng/mL if no prior orchiectomy
- No metastatic disease by bone scan and CT scan or MRI of the abdomen and
pelvis and by CT scan or x-ray of the chest
- No active or prior CNS metastases
Prior/Concurrent Therapy:
Biologic therapy: - Must have prior vaccinia for smallpox immunization
- No other concurrent biologic therapy
Chemotherapy: - No prior chemotherapy for prostate cancer
- No concurrent chemotherapy
Endocrine therapy: - See Disease Characteristics
- At least 4 weeks since prior hormonal therapy (6 weeks for
bicalutamide) and recovered
- If disease progression on LHRH antagonist, must continue to
receive that LHRH agent or undergo surgical castration
- No concurrent steroids unless topical or inhaled
- No other concurrent hormonal therapy
Radiotherapy: - At least 4 weeks since prior radiotherapy and
recovered
- No prior radiotherapy to more than 50% of nodal
groups
- No concurrent radiotherapy
Surgery: - See Disease Characteristics
- See Endocrine therapy
- At least 4 weeks since prior surgery and recovered
- No prior splenectomy
Other: - No concurrent homeopathic therapy with PC-SPES or
genistein
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Absolute lymphocyte count at least 600/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 8.0 g/dL
Hepatic: - Bilirubin no greater than 1.6 mg/dL
- AST and ALT no greater than 4 times normal
Renal: - Creatinine no greater than 1.5 mg/dL
OR - Creatinine clearance greater than 60 mL/min
- Urinalysis normal
OR - Proteinuria no greater than 1 g/24-hour urine collection
- No hematuria or abnormal sediment unless underlying cause is
nonrenal
Immunologic: - HIV negative
- No altered immune function
- No autoimmune disease, including the following:
- Autoimmune neutropenia, thrombocytopenia, or hemolytic
anemia
- Systemic lupus erythematosus, Sjogren's syndrome, or
scleroderma
- Myasthenia gravis
- Goodpasture syndrome
- Addison's disease, Hashimoto's thyroiditis, or active Graves'
disease
- No known allergy or untoward reaction to prior vaccination
with vaccinia virus
- No known allergy to eggs
- No active or prior eczema or other eczematoid skin
disorders
- No other acute, chronic, or exfoliative skin conditions (e.g.,
atopic dermatitis, impetigo, varicella zoster, burns, severe acne,
or other open rashes or wounds)
Other: - No other serious concurrent illness
- No active infections within the past 3 days
- No history of seizures, encephalitis, or multiple
sclerosis
- No close or household contact for at least 2 weeks after
each vaccinia virus inoculation with the following high-risk
individuals:
- Children under 5 years of age
- Pregnant or nursing women
- Individuals with active or prior eczema or other eczematoid
skin disorders, atopic dermatitis, impetigo, varicella zoster, burns,
severe acne, or other open rashes or wounds
- Immunosuppressed or immunodeficient (by disease or therapy)
individuals, including those with HIV infection
- No other malignancy within the past 3 years except squamous
cell or basal cell skin cancer or other curatively treated
malignancy
Expected Enrollment A total of 56-78 patients (28-39 per treatment arm) will be accrued for this
study within 1.5-2 years. Outline This is a randomized study. Patients are stratified according to HLA-A2
typing (positive vs negative). Patients are randomized to one of two
treatment arms. Treatment continues in both arms for at least 6 months in the absence of
disease progression or unacceptable toxicity. After 6 months of therapy, patients with a rising PSA and no
radiographic evidence of disease progression may receive therapy in the other
arm in addition to the therapy to which they were randomized. Patients are followed monthly for 6 months and then every 2 months
thereafter. Published ResultsArlen PM, Gulley JL, Todd N, et al.: Antiandrogen, vaccine and combination therapy in patients with nonmetastatic hormone refractory prostate cancer. J Urol 174 (2): 539-46, 2005.[PUBMED Abstract] Arlen PM, Gulley JL, Novik L, et al.: A randomized phase II trial of either vaccine therapy (recombinant pox viruses expressing PSA and the B7.1 costimulatory molecule) versus hormone therapy (nilutamide) in patients with hormone refractory prostate cancer and no radiographic evidence of disease. [Abstract] J Urol 169 (4 Suppl): A-941, 243, 2003. Arlen PM, Gulley J, Novik L, et al.: A randomized phase II trial of either vaccine therapy (recombinant pox viruses expressing PSA and the B7.1 costimulatory molecule) versus hormone therapy (nilutamide) in patients (pts) with hormone refractory prostate cancer and no radiographic evidence of disease. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-728, 2002. Related PublicationsTsang KY, Zhu M, Even J, et al.: The infection of human dendritic cells with recombinant avipox vectors expressing a costimulatory molecule transgene (CD80) to enhance the activation of antigen-specific cytolytic T cells. Cancer Res 61 (20): 7568-76, 2001.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research-Medical Oncology | | | Philip Arlen, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Randomized Phase II Study of Either Immunotherapy with a Regimen of Recombinant Pox Viruses That Express PSA/B7.1 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy with Nilutamide in Patients with Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease | | Trial Start Date | | 2000-06-29 | | Registered in ClinicalTrials.gov | | NCT00020254 | | Date Submitted to PDQ | | 2000-06-28 | | Information Last Verified | | 2003-04-21 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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