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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

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 rea...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • 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.
• PRIOR/CONCURRENT THERAPY:
• Biologic Therapy:
• • No concurrent Biologic Therapy.
• • Must fully recover from prior Biologic Therapy.
• Chemotherapy:
• • 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.
• Radiotherapy:
• • At least 4 weeks since prior radiation therapy and fully recovered.
• • No prior radiotherapy to more than 50% of nodal groups.
• • No concurrent radiotherapy.
• Surgery:
• • At least 4 weeks since prior surgery, with surgical scar healed.
• • No prior splenectomy.
• PATIENT CHARACTERISTICS:
• • Age: Over 18.
• • Performance status: Zubrod (ECOG) 0-2.
• Hematopoietic:
• • Absolute granulocyte count greater than 2,000/mm(3);
• • Platelet count greater than 100,000/mm(3);
• • Hemoglobin greater than 8.0 g/dL.
• Hepatic:
• • Bilirubin less than 1.6 mg/dL;
• • AST and ALT less than 4 times normal.
• • Renal: Creatinine less than 1.6 mg/dL.
• Immunologic:
• • 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.
• OTHER:
• • 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 individuals.
• • 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.