NCT00003021

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of bizelesin in treating patients who have advanced cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1997

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

March 12, 2004

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

5.3 years

First QC Date

November 1, 1999

Last Update Submit

November 2, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

bizelesinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor for which there are no therapeutic options that are potentially curative or have been demonstrated to increase survival No primary or metastatic CNS malignancy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No atrial or ventricular arrhythmia requiring medication No ischemic event within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No other serious concurrent medical illness No history of seizure disorder requiring active therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 10% of bone marrow No prior electron-beam radiotherapy At least 4 weeks since other prior radiotherapy Surgery: Prior surgery allowed Other: Recovered from prior therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Cancer Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

bizelesin

Study Officials

  • Eric K. Rowinsky, MD

    The University of Texas Health Science Center at San Antonio

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 12, 2004

Study Start

August 1, 1997

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

US(2)