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Vaccine Therapy in Treating Patients With Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Vaccine Therapy in Treating Patients With Metastatic Breast Cancer

A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adenocarcinoma of the Breast

NCT00003761•Dana-Farber Cancer Institute

View on ClinicalTrials.gov

Summary

This protocol is designed to evaluate the side effects of rV-DF3/MUC1 and to determine the safest dose which should be used in the treatment of breast cancer.

Detailed Description

OBJECTIVES: I. Determine the toxicity associated with repeated vaccination with recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) in patients with metastatic breast cancer. II. Determine the maximum tolerated dose of rV-DF3/MUC1, based on cellular and humoral immunity, in these patients. III. Determine whether vaccination with rV-DF3/MUC1 is associated with antitumor activity in these patients. OUTLINE: This is an open label, dose escalation study. Patients receive recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) intradermally. Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of rV-DF3/MUC1 until the maximum tolerated dose (MTD) or the highest dose level to be tested is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 1-2 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a histologically confirmed diagnosis of metastatic adenocarcinoma of the breast. Patients may have measurable disease, but it is not required. Patients may have received any number of prior therapies for metastatic disease. Untreated patients are also eligible.
•Age ≥ 18 years
•Patients must have an ECOG = Performance Status of 0-1
•Patients must have a WBC \> 2000/mm 3 and a platelet count \> 100,000/mm3.
•Patients must have adequate renal function documented by a serum creatinine \< 2.0 mg/d1.
•Patients must have adequate liver function demonstrated by a serum bilirubin \< 2.0 mg/di, and a SGPT \< 4 times the upper limit of normal.
•≥3 weeks since chemotherapy (\> 6 weeks for nitosoureas or mitomycin C), hormonal therapy or radiation therapy
•Immunologic testing must be at least normal as defined by at least normal delayed type hypersensitivity, at least normal CD4: CD8 ratio (\>1), at least normal lymphocyte proliferation testing (to Con A), and at least normal immunoglobulin levels
•Patients must not have evidence of altered immune responsiveness or autoimmune syndromes (scleroderma,systemic lupus erythematosus, etc.). Patients must be HIV negative. This treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity.
•Patients must not have undergone splenectomy.
+1 more criteria

Exclusion Criteria

•Patients must be able to avoid close contact with children \< 3 years of age, pregnant women, individuals with eczema or skin conditions and immune suppressed individuals during a period of two weeks after each vaccination.
•Patients must have had prior vaccinia (small pox) exposure.
•Tumor tissue positive for staining with MAbs DF3 and/or DF3-P or elevated serum CA15-3. Note: This can be done on stored slides.
•Patients must not have a history of seizures, encephalitis or multiple sclerosis.
•Patients must not be allergic to eggs.
•Patients must not be pregnant or breast-feeding due to a possible increased risk with exposure to vaccinia virus of both mother and newborn as well as unknown risks to the fetus.
•Signed informed consent.
•Patients must not have evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.). Patients must be HIV negative This treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity.
•Patients must not have undergone splenectomy
•Patients with active cases or history of extensive skin disorders (such as extensive psoriasis, burns, impetigo, disseminated zoster) are ineligible.

Locations (4)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

March 3, 1999

Primary Completion Date

April 20, 2001

Completion Date

October 19, 2001

Last Updated

February 15, 2017

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

rV-DF3/MUC1

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vaccine Therapy in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer