NCT00004147

Brief Summary

RATIONALE: COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of COL-3 in treating patients who have progressive or recurrent brain tumors following radiation therapy or chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_1

Geographic Reach
1 country

9 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

First Submitted

Initial submission to the registry

December 10, 1999

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

June 21, 2013

Status Verified

May 1, 2003

First QC Date

December 10, 1999

Last Update Submit

June 20, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

incyclinideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven high grade glioma that is progressive or recurrent following radiotherapy or chemotherapy * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Prior low grade glioma that has progressed to high grade glioma following radiotherapy and/or chemotherapy allowed * Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No myocardial infarction, stroke, or congestive heart failure within the past 3 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study * No serious active infection or medical illness that would preclude compliance * HIV negative * No history of gastrointestinal disorders that would interfere with absorption of study drug * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, or basal cell or squamous cell skin cancer * No hypersensitivity to tetracyclines or its derivatives PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas) and recovered * No more than 2 prior chemotherapy regimens Endocrine therapy: * Not specified Radiotherapy: * No prior large field radiotherapy (greater than 20% of total bone marrow) * At least 3 months since other prior radiotherapy and recovered Surgery: * No prior major upper gastrointestinal surgery * At least 14 days since other prior major surgery Other: * No other concurrent investigational agents * No prolonged sun exposure

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

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Related Publications (1)

  • Rudek MA, New P, Mikkelsen T, Phuphanich S, Alavi JB, Nabors LB, Piantadosi S, Fisher JD, Grossman SA. Phase I and pharmacokinetic study of COL-3 in patients with recurrent high-grade gliomas. J Neurooncol. 2011 Nov;105(2):375-81. doi: 10.1007/s11060-011-0602-9. Epub 2011 May 6.

    PMID: 21547395RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaOligodendrogliomaGliosarcoma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Pamela Z. New, 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

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

July 1, 2000

Study Completion

November 1, 2006

Last Updated

June 21, 2013

Record last verified: 2003-05

Locations

US(9)