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Phase II Randomized Study of Recombinant Fowlpox Prostate-Specific Antigen (PSA) Vaccine and Recombinant Vaccinia-PSA Vaccine in Patients With Advanced Adenocarcinoma of the Prostate
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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NCI
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DFCI-98262 NCI-T98-0004, NCT00005039, T98-0004
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Objectives - Determine the toxicity and maximum tolerated dose of recombinant fowlpox prostate-specific antigen (PSA) vaccine in patients with advanced adenocarcinoma of the prostate.
- Determine whether vaccination with recombinant fowlpox-PSA vaccine is associated with antitumor activity in these patients.
- Determine the efficacy of prime and boost regimens using recombinant fowlpox-PSA vaccine and recombinant vaccinia-PSA vaccine in these patients.
- Compare the PSA-specific T-cell response in patients treated with recombinant fowlpox-PSA vaccine followed by recombinant vaccinia-PSA vaccine vs the same vaccines but in reverse order.
Entry Criteria Disease Characteristics:
- Histologically proven adenocarcinoma of the prostate with evidence of
metastatic disease including any of the following:
- Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL
- Bone scan positive and PSA at least 10 ng/mL
- Prior radical prostatectomy with rising PSA and PSA at
least 2 ng/mL
- Prior radiotherapy and PSA at least 10 ng/mL
- Prior cryosurgery and PSA at least 10 ng/mL
- PSA criteria does not apply to patients who are
assigned to group B of this
study and were previously treated on vaccine trial
DFCI-96079
- No symptomatic metastatic disease (no bony pain)
- Complete HLA typing required
Prior/Concurrent Therapy:
Biologic therapy: - See Disease Characteristics
- See Endocrine therapy
- Prior vaccinia (smallpox) immunization required
- No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer
Chemotherapy: - No prior chemotherapy for metastatic disease
- No concurrent anticancer chemotherapy
Endocrine therapy: - No prior hormonal therapy for metastatic disease
- Prior neoadjuvant hormonal therapy followed by prostatectomy
or radiotherapy allowed
- Patients previously treated with recombinant vaccinia-PSA
vaccine may have hormonal therapy since discontinuing that treatment (Group
B)
- No concurrent hormonal therapy or steroids
Radiotherapy: - See Disease Characteristics
- See Endocrine therapy
- No concurrent radiotherapy
Surgery: - See Disease Characteristics
- See Endocrine therapy
- No prior splenectomy
Other: - At least 3 days since prior antibiotics
- No concurrent immunosuppressive treatment (e.g., after organ
transplantation)
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC greater than 2,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic: - Bilirubin less than 2.0 mg/dL
- SGPT less than 4 times upper limit of normal
Renal: - Creatinine less than 4.0 mg/dL
Immunologic: - No altered immune function such as eczema
- No autoimmune diseases such as the following:
- Autoimmune neutropenia, thrombocytopenia, or hemolytic
anemia
- Systemic lupus erythematosus, Sjögren's syndrome, or
scleroderma
- Myasthenia gravis
- Goodpasture's syndrome
- Addison's disease, Hashimoto's thyroiditis, or active Graves'
disease
- HIV negative
- No allergy or untoward reaction to prior vaccinia (smallpox)
vaccination
- No hypersensitivity to eggs
Other: - No prior or concurrent extensive eczema or skin disorders
(e.g., extensive psoriasis, burns, impetigo, or disseminated zoster)
- No other concurrent serious illness
- No active infection requiring antibiotics until infection has
cleared and antibiotics have been stopped for at least 3 days
- Fertile patients must use effective contraception
- No close contact or household contact with the following
high-risk individuals for at least 2 weeks after each
vaccination:
- Children under age 5
- Pregnant or nursing women
- Individuals with prior or concurrent extensive eczema or
other eczematoid skin disorders
- Individuals with other acute, chronic, or exfoliative skin
conditions (e.g., atopic dermatitis, burns, impetigo, varicella
zoster, severe acne, or other open rashes or wounds)
- Immunodeficient or immunosuppressed individuals (by disease
or therapy) such as those with HIV infection
Expected Enrollment Approximately 6-86 patients (6 in the safety cohort, 15-20 per arm in group A,
and approximately 10 in group B) will be accrued for this study within 1 year. Outline This is a randomized, open-label, multicenter, dose-escalation study of
recombinant fowlpox prostate-specific antigen (PSA) vaccine. - Safety cohort: The first cohort of 3 patients receives vaccination with
recombinant fowlpox-PSA vaccine intramuscularly (IM). Treatment repeats every
4 weeks for 3 courses. In the absence of unacceptable toxicity in the first
cohort, the second cohort of 3 patients receives the same vaccine at the dose
level immediately higher than the first cohort dose level. In the presence of
unacceptable toxicity in the first cohort, the second cohort of 3 patients
receives the same vaccine at a dose level lower than the first cohort dose
level. The maximum tolerated dose (MTD) is the dose preceding that at which 1
of 6 patients experiences grade 3 or worse dose-limiting toxicity.
Subsequent patients are assigned to one of two vaccination groups based
on prior treatment with recombinant vaccinia-PSA vaccine: - Group A (no prior recombinant vaccinia-PSA vaccine): Patients are
randomized to one of two vaccination arms:
- Arm I: Patients receive recombinant fowlpox-PSA vaccine IM at the
MTD from the safety cohort every 4 weeks for 3 courses. Patients then
receive recombinant vaccinia-PSA vaccine intradermally every 4 weeks for 2
courses.
- Arm II: Patients receive the same vaccines as in arm I but in
reverse order.
- Group B (prior recombinant vaccinia-PSA vaccine): Patients receive
treatment as in arm I, group A.
- Groups A and B: Patients with stable or responding disease at 6 months
after completion of vaccination therapy may continue treatment on the group
and arm to which they were originally assigned. Treatment repeats every 6-9
months in the absence of disease progression.
Patients are followed monthly for 6 months and then every 3 months thereafter.
Trial Contact Information
Trial Lead Organizations Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | Joseph Paul Eder, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) |
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients with Adenocarcinoma of the Prostate | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2000-01-04 | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00005039 | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2000-02-04 | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2003-11-23 | ![](https://webarchive.library.unt.edu/eot2008/20081015152300im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | CA06516, CA62490 |
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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