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COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00004147
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

New Approaches to Brain Tumor Therapy Consortium
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pamela Z. New, MD
Principal Investigator Affiliation The University of Texas Health Science Center at San Antonio
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine the maximum tolerated dose, dose limiting toxicity, and safety profile of oral COL-3 alone or when combined with anticonvulsants known to be metabolized by CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme.
  • - Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics.
  • - Determine the response rate, disease free survival, and survival in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study of COL-3. Patients are stratified by anticonvulsant (anticonvulsants that cause induction of CYP450 vs.#46;anticonvulsants that cause modest or no induction of CYP450 or no anticonvulsant).
  • - Phase I: Patients receive oral COL-3 daily.
Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
  • - Phase II: Patients receive oral COL-3 daily at the MTD from the phase I portion of this study.
Patients are followed every 2 months until death. PROJECTED ACCRUAL: A total of 15-18 patients will be accrued for phase I of the study and a total of 35 patients will be accrued for phase II of the study at a rate of 3 patients per month.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497

Emory University Hospital - Atlanta, Atlanta, Georgia

Status

Address

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Henry Ford Hospital, Detroit, Michigan

Status

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Winston-Salem, North Carolina

Status

Address

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811