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Vaccine Therapy in Treating Patients With Metastatic Breast Cancer

Primary Purpose

Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant vaccinia-MUC1 vaccine
recombinant vaccinia-TRICOM vaccine
laboratory biomarker analysis
quality-of-life assessment
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must have a histologically confirmed diagnosis of metastatic carcinoma of the breast; measurable disease is not required; subjects who are NED are eligible; subjects must have had at least one prior regimen of chemotherapy, immunotherapy, or hormonal therapy prior to entering this study; subjects may have received any number of prior therapies for metastatic disease Subjects must have an ECOG performance status of 0-1 WBC > 2000/mm^3 Platelet count > 100,000/mm^3 Serum creatinine =< 2.0 mg/dl Serum bilirubin =< 1.5 mg/dl SGPT < 3 times the upper limit of normal >= 4 weeks since chemotherapy (>= 6 weeks for nitrosoureas or mitomycin C), hormonal therapy or radiation therapy; subjects must have recovered from all acute toxicity associated with the prior regimen; subjects receiving concurrent hormonal treatment or local radiation are not eligible Subjects must be HLA typed if not already previously done (5/10 subjects at the MTD dose level must be HLA A2 positive) Subjects must not have clinical evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.); subjects must be HIV antibody negative; this treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity Subjects must not have undergone splenectomy The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least three weeks after vaccination, their close household contacts: persons with active or a history of extensive eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection; close household contacts are those who share housing or have close physical contact; determination of the severity of these conditions will be made by the investigator or co-investigator Subjects must not have any other serious medical condition that in the opinion of the investigator is incompatible with the protocol; subjects with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days Subjects must have had prior vaccinia (smallpox) exposure, determined by subject history, medical documentation, or scar characteristic of vaccinia exposure; there must be no history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination Tumor tissue positive for staining with MAbs DF3 and/or DF3-P or elevated serum CA15-3 (also known as CA27-29); note: this can be done on stored slides, but subject will be responsible for costs if not covered by insurance Subjects must not have a history of seizures, encephalitis or multiple sclerosis Subjects must not be allergic to eggs Women of child-bearing potential must agree to use highly effective contraception or abstinence prior to study entry and for at least 4 weeks after the last vaccination; women who are breast-feeding are not eligible for this study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Signed informed consent Participants who have been previously treated with vaccinia vectors or MUC1 such as those on protocol T98-0057 (DFPCC # 97-050) are not eligible for this study

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (vaccine therapy)

Arm Description

Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

MTD defined as the dose level preceding the dose in which 2 out of 6 patients experience dose limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Toxicity Criteria version 2.0

Secondary Outcome Measures

Full Information

First Posted
November 4, 2003
Last Updated
December 10, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00071942
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Breast Cancer
Official Title
A Phase I Trial of An Admixture of Recombinant Vaccinia Virus That Express DF3/MUC1 and rV-TRICOM (B7.ICAM-1, and LFA-3) in Patients With Metastatic Adenocarcinoma of The Breast
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Study Start Date
October 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Vaccines may make the body build an immune response to kill tumor cells. This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic breast cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the toxicity associated with repeated vaccination with an admixture of recombinant vaccinia viruses (rV-MUC-1 and rV-TRICOM). II. To determine the maximum tolerated dose (MTD) of rV-MUC-1 and rV-TRICOM vaccine admixture. III. To evaluate the toxicity of adding GM-CSF to the admixture of the rV-MUC-1 and rV-TRICOM. SECONDARY OBJECTIVES: I. To assess host immune reactivity following rV-MUC-1 and rV-TRICOM with and without GM-CSF administration. II. To determine whether vaccination with rV-MUC-1 and rV-TRICOM with and without GM-CSF is associated with antitumor activity. OUTLINE: This is an open-label, dose-escalation study. Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients (including 5 HLA-A2-positive patients) receive vaccination as above at the MTD and sargramostim (GM-CSF) subcutaneously on days 1-4 and 29-32. Patients are followed at 4 weeks, monthly until disease progression, and then annually for up to 15 years. PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study within 18-24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (vaccine therapy)
Arm Type
Experimental
Arm Description
Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
recombinant vaccinia-MUC1 vaccine
Other Intervention Name(s)
recombinant vaccinia-MUC-1 vaccine, rV-MUC-1, vaccinia-MUC-1 vaccine
Intervention Description
Given intradermally
Intervention Type
Biological
Intervention Name(s)
recombinant vaccinia-TRICOM vaccine
Other Intervention Name(s)
rV-TRICOM, Vaccinia-TRICOM
Intervention Description
Given intradermally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
MTD defined as the dose level preceding the dose in which 2 out of 6 patients experience dose limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Toxicity Criteria version 2.0
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have a histologically confirmed diagnosis of metastatic carcinoma of the breast; measurable disease is not required; subjects who are NED are eligible; subjects must have had at least one prior regimen of chemotherapy, immunotherapy, or hormonal therapy prior to entering this study; subjects may have received any number of prior therapies for metastatic disease Subjects must have an ECOG performance status of 0-1 WBC > 2000/mm^3 Platelet count > 100,000/mm^3 Serum creatinine =< 2.0 mg/dl Serum bilirubin =< 1.5 mg/dl SGPT < 3 times the upper limit of normal >= 4 weeks since chemotherapy (>= 6 weeks for nitrosoureas or mitomycin C), hormonal therapy or radiation therapy; subjects must have recovered from all acute toxicity associated with the prior regimen; subjects receiving concurrent hormonal treatment or local radiation are not eligible Subjects must be HLA typed if not already previously done (5/10 subjects at the MTD dose level must be HLA A2 positive) Subjects must not have clinical evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.); subjects must be HIV antibody negative; this treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity Subjects must not have undergone splenectomy The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least three weeks after vaccination, their close household contacts: persons with active or a history of extensive eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection; close household contacts are those who share housing or have close physical contact; determination of the severity of these conditions will be made by the investigator or co-investigator Subjects must not have any other serious medical condition that in the opinion of the investigator is incompatible with the protocol; subjects with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days Subjects must have had prior vaccinia (smallpox) exposure, determined by subject history, medical documentation, or scar characteristic of vaccinia exposure; there must be no history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination Tumor tissue positive for staining with MAbs DF3 and/or DF3-P or elevated serum CA15-3 (also known as CA27-29); note: this can be done on stored slides, but subject will be responsible for costs if not covered by insurance Subjects must not have a history of seizures, encephalitis or multiple sclerosis Subjects must not be allergic to eggs Women of child-bearing potential must agree to use highly effective contraception or abstinence prior to study entry and for at least 4 weeks after the last vaccination; women who are breast-feeding are not eligible for this study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Signed informed consent Participants who have been previously treated with vaccinia vectors or MUC1 such as those on protocol T98-0057 (DFPCC # 97-050) are not eligible for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Eder
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Metastatic Breast Cancer

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