Vaccine Therapy in Treating Women With Previously Treated Metastatic Breast Cancer

NCT00706615 | Withdrawn Phase 1 DMC

• 2 other identifiers: CDR0000599060UCLA-07-05-056
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating women with previously treated metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (2)

• Characterize the safety profile of the Ad-sig-hMUC-1/ecdCD40L vector vaccine

• Identification of a tolerable, immunologically active dose level

Secondary Outcomes (1)

• Assess efficacy based on serum MUC-1 level

Interventions

Ad-sig-hMUC-1/ecdCD40L vaccine BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Women over the age of 18 with metastatic or non-measureable adenocarcinoma of the breast with marrow involvement.
• Elevated serum MUC-1 levels, as measured by CA 15-3 or CA 27-29
• Stable disease (defined as fluctuation of \<50U in CA15-3 or CA27-29 value) for at least 3 months while either on no breast-cancer therapy or while on current therapy (Tamoxifen, fulvestrant, exemestane, letrozole, anastrozole, bisphosphonates or trastuzumab chemotherapy is not allowed)
• ability to understand the risks, benefits, and procedures and provide written informed consent.
• less than 28 days prior to enrollment since last surgery and/or radiation therapy.
• performance status \<=2 on the ECOG performance scale and life expectancy of greater than 12 months
• NYHA cardiac function Class I or Class II and normal baseline ECG. If ECG is abnormal, patient must have an echocardiogram showing a left ventricular ejection fraction greater than the lower limits of normal.
• patients who do not have radiographically assessable locally recurrent or metastatic disease are eligible if they 1) had radiographic or biopsy proven locally recurrent or metastatic breast cancer in the past and 2) currently (at study entry) have an elevated serum MUC-1 level (as measured by CA 15-3 or CA 27-29).
• Acceptable pulmonary function. if questionable, a pulmonary function test will be performed.
• negative serology for hepatitis B, C and HIV.
• red cell mean corpuscular volume \>- 80 cu. mm, hemoglobin \>- 8g/dl, platelet count \>- 100,000/dl: AST, ALT, LDH \<-2 times the Upper limit of normal
• Serum creatinine \< 1.6 mg/dL
• for women with child bearing potential, Negative urine pregnancy test within 7 days of registration and willingness to use an approved contraceptive method while participating in this trial.

You may not qualify if:

• history of bronchospasm or asthma requiring inhaled or oral steroid treatment
• Normal MUC-1 (CA 15-3 or CA 27-29)
• treatment with steroid or other immunosuppressive medication (for any condition ) within 30 days of trial registration.
• history of any autoimmune disease (e.g., lupus, rheumatoid arthritis, or psoriasis)
• uncontrolled diabetes mellitus
• unable or unwilling to undergo repeated clinical evaluations and other diagnostic procedures or unable to sign an informed consent.
• history of other malignancies, except squamous cell or basal cell carcinoma of the skin or cervical carcinoma in situ.
• Concurrent systemic chemotherapy (tamoxifen, aromatase inhibitors, fulvestrant, trastuzumab and biophosphonates are allowed if started more than 3 months prior to trial registration with evidence of stable disease as defined above. Chemotherapy must have stopped 3 months prior to enrolling in this trial).
• history of ornithine transcarbamylase deficiency
• any acute or chronic viral, bacterial, or fungal infection requiring specific therapy, unless acute therapy was completed within the past 14 days
• No underlying conditions that would contraindicate therapy with study treatment ( or allergies to reagents used in this study)
• history of organ transplant or allogeneic bone marrow transplant
• life threatening or organ-threatening disease expected to require conventional therapy within 4 months.
• pregnant or nursing females.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, 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

• Sara Hurvitz, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 27, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Last Updated: July 31, 2020

Record last verified: 2012-07

Locations

US (1)