Know Cancer

forgot password

A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate

Phase 1
Not Enrolling
Prostatic Neoplasms

Thank you

Trial Information

A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate

This trial will evaluate, in patients with metastatic prostate cancer, the tolerability,
toxicities, efficacy, and immunologic effects of repeated vaccinations with a recombinant
vaccinia virus that contains the Prostate Specific Antigen gene (PROSTVAC). Patients with
PSA-expressing adenocarcinoma of the prostate will be evaluated for eligibility that
includes a history of prior vaccinia (as vaccine against smallpox) and immunocompetence. We
completed a phase I trial investigating the use of rV-CEA in adenocarcinomas of the GI
tract, lung and breast. The toxicities encountered are local reactions to the vaccine. We
did not encounter any myelosuppression or systemic autoimmune reaction. We would like to
evaluate four doses to ensure safety and to decide a best biological dose. Six patients
will receive 2.65 x 10(5) PFU and 2.65 x 10(6) PFU of vaccine by scarification. Because
higher doses cannot be achieved by scarification, six patients will receive 2.65 x 10(7) PFU
and 2.65 x 10(8) PFU subcutaneously. We plan to give three vaccinations at four week
intervals. All six patients treated in each dose level must be evaluable for 4 weeks before
enrolling patients at the higher dose level. No intrapatient escalation is planned.
Toxicity, tumor response, and humoral and cellular immunity factors will be monitored.
Optional lymphapheresis will be done on patients that are HLA A2. Once we determined the
best biological dose, we would like to accrue an additional 6 patients to that level.

Inclusion Criteria


Histologically confirmed adenocarcinoma of the prostate as follows: Unresectable and/or
incurable tumor AND Tumor progression after at least 1 prior hormonal manipulation (i.e.,
LHRH agonist/flutamide or orchiectomy). LHRH agonist may by continued concurrently with
protocol therapy.

New bone or soft tissue lesions OR Serum PSA that has risen on 3 successive evaluations at
least 1 week apart during and/or after hormonal therapy. If PSA is below 4 ng/mL,
measurable disease with positive immunohistochemical stain for PSA is required.

No history of allergy to eggs.

No history of or active CNS metastases.

Symptomatic spinal or other bony metastasis should be irradiated prior to entry.

Bi-dimensionally measurable disease not required.


Biologic Therapy:

No concurrent Biologic Therapy.

Must fully recover from prior Biologic Therapy.


At least 4 weeks since prior chemotherapy and fully recovered.

No more than 1 prior chemotherapy regimen.

No concurrent chemotherapy.

Endocrine Therapy:

See Disease Characteristics.

At least 4 weeks since prior hormonal therapy and fully recovered.

No concurrent steroids.


At least 4 weeks since prior radiation therapy and fully recovered.

No prior radiotherapy to more than 50% of nodal groups.

No concurrent radiotherapy.


At least 4 weeks since prior surgery, with surgical scar healed.

No prior splenectomy.


Age: Over 18.

Performance status: Zubrod (ECOG) 0-2.


Absolute granulocyte count greater than 2,000/mm(3);

Platelet count greater than 100,000/mm(3);

Hemoglobin greater than 8.0 g/dL.


Bilirubin less than 1.6 mg/dL;

AST and ALT less than 4 times normal.

Renal: Creatinine less than 1.6 mg/dL.


Prior vaccinia (for smallpox immunization) required, with proof of vaccination as follows:
Detectable anti-vaccinia antibodies, Physician certification of prior vaccination, Patient
recollection or appropriate vaccination-site scar sufficient in patients over age 25,
Delayed-type hypersensitivity skin testing (to mumps, Candida, and Trichophyton antigens)
normal Quantitative immunoglobulins normal.

No evidence of immunocompromise, i.e.:

No HIV antibody;

No eczema or atopic dermatitis;

No autoimmune neutropenia, thrombocytopenia, or hemolytic anemia;

No systemic lupus erythematosus, Sjogren syndrome, or scleroderma;

No myasthenia gravis;

No Goodpasture syndrome;

No Addison's disease, Hashimoto's thyroiditis, or active Graves' disease;

No other autoimmune disease or diagnosis of altered immune function.


No active case or history of extensive psoriasis, severe acneiform rash, impetigo,
varicella zoster, burns, or other traumatic or pruritic skin condition.

No active infection requiring antibiotics (including chronic suppressive therapy). At
least 3 days since antibiotic therapy.

No history of seizures, encephalitis, or multiple sclerosis.

No other serious intercurrent illness.

Able to avoid close contact with the following individuals for at least 2 weeks after
vaccination (i.e., no such individuals as household members and no care-giving
responsibilities for such individuals): Children under age 3, Pregnant women, Individuals
with eczema or skin conditions defined above, Leukemia or lymphoma patients, HIV-positive
individuals, Patients receiving immunosuppressive therapy, Any other immunosuppressed

No prior malignancy unless curatively treated and patient has been in remission for at
least 2 years (excluding squamous cell or basal cell carcinoma of the skin or carcinoma in
situ of the cervix).

Able and willing to travel to the NIH, NCI-NMOB, or the Lombardi Cancer Center at
Georgetown University for treatment and follow-up.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

March 1994

Completion Date:

March 2000

Related Keywords:

  • Prostatic Neoplasms
  • Immunotherapy
  • Vaccine
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Prostatic Neoplasms
  • Vaccinia



National Cancer Institute (NCI) Bethesda, Maryland  20892