Completed

Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer

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What is being tested

irofulven

Drug
Who is being recruted

Breast Diseases+4

+ Neoplasms

+ Neoplasms by Site

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 1999
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven. II. Assess the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

NCT00003796
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast NeoplasmsBreast Neoplasms, Male

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the breast Measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy Must have received 1 or 2 prior chemotherapy regimens for metastatic disease More than 3 prior regimens allowed No active brain metastases or meningeal breast cancer involvement PATIENT CHARACTERISTICS: Sex: Male or female Performance status: SWOG 0-2 Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of myocardial infarction or unstable angina within the past 6 months No uncontrolled congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease) No history of retinopathy and/or macular degeneration PRIOR CONCURRENT THERAPY: Chemotherapy: No prior irofulven

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas Health Science Center at San Antonio

San Antonio, United StatesOpen University of Texas Health Science Center at San Antonio in Google Maps
CompletedOne Study Center