Neoplasms

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Breast Neoplasms

Vaccinia

Breast Diseases

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Vaccines

Immunologic Factors

recombinant modified vaccinia Ankara-5T4 vaccine

adjuvant therapy

recombinant viral vaccine therapy

Lupe G. Salazar, MD

Mary (Nora) L. Disis, MD

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission.

OBJECTIVES:

* Determine the feasibility of conducting a live viral vaccine trial using adjuvant recombinant modified vaccinia Ankara-5T4 vaccine (TroVax®) in patients with stage IIIB-IV breast cancer in remission.
* Determine the progression-free survival of patients treated with this vaccine.
* Determine the 5T4-specific T-cell immune response in patients treated with this vaccine.
* Determine the toxicity of this vaccine in these patients.
* Determine the level of 5T4-specific antibody response in patients treated with this vaccine.
* Correlate, preliminarily, immune response with 3- and 12-month progression-free survival of patients treated with this vaccine.
* Correlate tumor 5T4 expression with overall survival and progression-free survival of patients treated with this vaccine.
* Correlate tumor infiltrating lymphocyte and CD1a-positive dendritic cell density with development of 5T4-specific T-cell immunity in patients treated with this vaccine.

OUTLINE: This is a multicenter study.

Patients receive recombinant modified vaccinia Ankara-5T4 vaccine (TroVax®) intramuscularly once a month in months 1-3. Patients then receive booster vaccinations once in months 6, 9, and 12. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.

S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission

S0348: A Phase II Study of 5T4-Modified Vaccinia Ankara (MVA) Vaccine (TROVAX) in Patients With Advanced Breast Cancer

National Cancer Institute (NCI)

SWOG Cancer Research Network

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Recurrence

Virus Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Molgramostim

Sargramostim

atients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF.

sargramostim

Donald W. Kufe, MD

Phase I trial to study the effectiveness of vaccine therapy in treating patients with metastatic prostate cancer. Vaccines may make the body build an immune response to kill tumor cells.

OBJECTIVES:

I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate.

II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity.

III. Determine whether vaccination with rV-PSA is associated with anti-tumor activity.

IV. Determine whether granulocyte-macrophage colony-stimulating factor (GM-CSF) has an effect on cellular and humoral immunity different from rV-PSA, and whether the addition of GM-CSF has enhanced antitumor effect compared to rV-PSA alone.

OUTLINE: This is an open label, dose escalation study.

Patients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF.

Patients are followed monthly for 6 months.

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission	NCT00227474	Breast Cancer	recombinant mod... adjuvant therap... recombinant vir...	18 Years -	SWOG Cancer Research Network
S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission	NCT00227474	Breast Cancer	recombinant mod... adjuvant therap... recombinant vir...	18 Years -	SWOG Cancer Research Network
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer	NCT00004029	Prostate Cancer	recombinant vir... sargramostim	18 Years -	National Cancer Institute (NCI)
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer	NCT00004029	Prostate Cancer	recombinant vir... sargramostim	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for recombinant viral vaccine therapy