Vaccine Therapy in Treating Patients With Metastatic Breast Cancer

NCT00003761 | Completed Phase 1 DMC

• 4 other identifiers: 97-050U01CA062490P30CA006516NCI-T98-0057
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Study Arms (1)

rV-DF3/MUC1

EXPERIMENTAL

* rV-DF3/MUC1 vaccinations will be administered 4 week intervals for a total of 3 doses. * Participants will be followed weekly until 28 days after the final dose (day 85) then month for 6 months

Biological: rV-DF3/MUC1

Interventions

rV-DF3/MUC1 BIOLOGICAL

\- The starting dose for this Phase I study of rV-DF3/MUC1 will be 4.76 x 106 PFU. \-- Dose escalation will proceed with cohorts of at least 6 patients as follows: Per vaccination * Level 1 4.76 x 106 PFU * Level 2 4.76 x 107 PFU * Level 3 4.76 x 108 PFU

rV-DF3/MUC1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with active cases or history of extensive skin disorders (such as extensive psoriasis, burns, impetigo, disseminated zoster) are ineligible.
• Patients must not have any other serious medical condition which in the opinion of the investigator is incompatible with the protocol. Patients with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days.
• 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.

You may not qualify if:

• 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.
• Patients must not have any other serious medical condition which in the opinion of the investigator is incompatible with the protocol. Patients with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Donald W. Kufe, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kufe, Donald William,M.D.

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: December 10, 2003
• Study Start: March 3, 1999
• Primary Completion: April 20, 2001
• Study Completion: October 19, 2001
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)