search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
incyclinide
Sponsored by
New Approaches to Brain Tumor Therapy Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Emory University Hospital - Atlanta
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts General Hospital Cancer Center
  • Henry Ford Hospital
  • Comprehensive Cancer Center at Wake Forest University
  • University of Pennsylvania Cancer Center
  • University of Texas Health Science Center at San Antonio

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
June 20, 2013
Sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00004147
Brief Title
COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
Official Title
A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2003
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
incyclinide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Z. New, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21547395
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs