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Breast CancerPhase 1/2NCT00066547

Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy

A Phase 1/2 study testing monoclonal antibody HuHMFG1 in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effect of monoclonal antibody therapy on the body and its effectiveness in treating women who have locally advanced or metastatic… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
monoclonal antibody HuHMFG1
How many people
Not given
Where
1 siteUnited States
Study dates
May 2003to not given
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer
  • Locally advanced or metastatic disease
  • No inflammatory breast cancer
  • Polymorphic epithelial mucin (PEM) antigen overexpression by immunohistochemistry
  • Previously treated with an anthracycline and a taxane in any combination for breast cancer
  • No more than 2 prior chemotherapy regimens, including adjuvant /neoadjuvant therapy
  • No more than 1 prior regimen for distant metastatic disease
  • Any number of prior hormonal or biologic therapy regimens allowed
  • Measurable disease
  • At least one unidimensionally measurable lesion not previously irradiated
  • The following are not considered measurable lesions:
  • Bone
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • No metastases accessible to complete surgical resection
  • No CNS metastasis by CT scan
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • WHO 0-2

Life expectancy

  • At least 4 months

Hematopoietic

  • Hemoglobin at least 10 g/dL
  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases are present)

Renal

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance greater than 60 mL/min
  • No hyperuricemia (uric acid at least 1.25 times ULN)
  • No hypercalcemia (calcium at least 11.5 mg/dL [corrected for serum albumin])

Cardiovascular

  • LVEF at least 45% by MUGA or echocardiogram within the past 4 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3-6 months after study participation
  • No other prior malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
  • No other concurrent uncontrolled comorbid illness that represents unacceptable risk in the opinion of the investigator
  • No legal incapacity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 2 weeks since prior growth factors to aid hematologic recovery
  • No other concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior cytotoxic chemotherapy
  • No concurrent chemotherapy for metastatic breast cancer

Endocrine therapy

  • See Disease Characteristics
  • No concurrent endocrine therapy for metastatic breast cancer
  • No concurrent chronic corticosteroid therapy
  • No concurrent high-dose corticosteroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy except for palliation
  • No concurrent antitumor radiotherapy except for palliation

Surgery

  • More than 4 weeks since prior major surgery

Other

  • More than 2 weeks since prior blood transfusions to aid hematologic recovery
  • No participation in any other investigational drug study
  • No other concurrent investigational drugs
  • No other concurrent antitumor therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: An Open Label Phase I/II Study of Humanized Human Milk Fat Globule-1 (THEREX) in Patients With Locally Advanced or Metastatic Breast Cancer Following Prior Anthracycline and Taxane Therapy

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effect of monoclonal antibody therapy on the body and its effectiveness in treating women who have locally advanced or metastatic breast cancer that was previously treated with combination chemotherapy.

Read the detailed description

OBJECTIVES:

  • Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with locally advanced or metastatic breast cancer previously treated with anthracycline and taxane-based therapy.
  • Determine the maximum tolerated dose and appropriate schedule of this drug in these patients.
  • Determine the pharmacokinetic profile of this drug in these patients.
  • Determine the tumor response rate, progression-free survival, and median survival of patients treated with this drug.
  • Analyze immunological markers for evaluation of disease status (e.g., in vitro analysis of antibody-dependent cellular cytotoxicity, natural killer cell activity, complement depletion, and tumor markers CA 15.3 and CEA) in patients treated with this drug.

OUTLINE: This is a dose-escalation, open-label, nonrandomized, multicenter study.

  • Phase I: Patients receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 3 weeks for doses 1 and 2. All subsequent dose intervals are based on individual half-life value of the drug. Patients receive at least 6 doses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuHMFG1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II:Patients receive monoclonal antibody HuHMFG1 as above at the MTD. Patients are followed at 28 days.

PROJECTED ACCRUAL: Approximately 3-40 patients (3-15 patients for phase I and 19-25 patients for phase II) will be accrued for this study within approximately 12 months.

Conditions
Breast Cancer
Being tested
monoclonal antibody HuHMFG1
Keywords
recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • monoclonal antibody HuHMFG1Biological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study startMay 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066547
Sponsor's protocol ID
CDR0000316264
Other IDs
UCLA-0212097, ANTISOMA-TOPCAT, ANTISOMA-ASM-THEREX-01
Status last verified
Aug 2004
First submitted
6 Aug 2003
Last updated
4 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing monoclonal antibody HuHMFG1 in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.

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