Adult Giant Cell GlioblastomaPhase 2NCT00004146
Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM
A Phase 2 study testing radiation therapy, carboxyamidotriazole and pharmacological study in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 8 sites in United States.
Trial summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
- What is being tested?
- radiation therapy, carboxyamidotriazole and pharmacological study
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2000to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- Patients must have measurable or non-measurable tumor on the post operative, pretreatment MRI/CT scan (within two weeks of starting treatment)
- Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
- Patients must have recovered from the immediate post-operative period and be maintained on a stable steroid regimen (no increase for the last five days)
- Absolute neutrophil count >= 1500/mm^3
- Platelets >= 100,000/mm^3
Show all 16Show fewer
- Hemoglobin concentration >= 9.0 g/dl
- Creatinine =< 1.7mg/dL
- Total bilirubin =< 1.2 mg/dl
- Transaminases =< 2 times above the upper limits of the institutional normal
- Estimated life expectancy greater than 2 months
- Patients must give informed consent and understand the investigational nature of this study and its potential risks and benefits
- Patients, if female and of childbearing potential must have a negative serum beta-hCG test and must not be breast feeding; all patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception
- Patients must have a Karnofsky performance status of >= 60%
- No other serious concurrent infection or other medical illness should be present which would jeopardize the ability of the patient to receive the drug outlined in this protocol with reasonable safety
- Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ; patients with prior malignancies must be disease-free for >= five years
Who cannot join
- Patients must be able to comply with prescribed medical care
- Prior therapy for the brain tumor (except surgery)
- Prior treatment with antineoplastic agents, including CAI
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama Birmingham
Birmingham, Alabama, 35294
Henry Ford Hospital
Detroit, Michigan, 48202
University of Pennsylavania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Moffitt Cancer Center
Tampa, Florida, 33612
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-Amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate overall survival rate in patients administered CAI (carboxyamidotriazole) and radiation therapy to adults with newly diagnosed glioblastoma multiforme.
II. To determine the toxicity of CAI when combined with cranial irradiation. III. To estimate correlations between pharmacokinetic parameters, including steady state CAI concentration, with toxicity and/or drug activity in this patient population.
IV. To estimate duration of disease free progression with this treatment regime.
OUTLINE: This is a multicenter study.
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.
- Being tested
- radiation therapy, carboxyamidotriazole, pharmacological study
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiotherapy
carboxyamidotriazoleDrug
Also called CAI, carboxyamido-triazole, carboxyaminoimidazole
Given orally
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (RT and CAI) | Experimental | Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.
Other: pharmacological study, radiation therapy Receives: Radiation: radiation therapy; Drug: carboxyamidotriazole; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Rate
estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death
Measured: approximately 30 months
Toxicity of CAI When Combined With RT
patients who experienced a grade 3 or higher event considered at least possibly related to CAI
Measured: pts were reviewed for toxicity while on treatement - median time of 2 months
Correlation Between PK CAI and Toxicity in This pt Population
PK paramenters including steady state CAI concentrations with toxicity/or drug activity
Measured: during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2004 (estimated)
- Study startMar 2000
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Giant Cell GlioblastomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tom Mikkelsen, MD, Principal investigator, New Approaches to Brain Tumor Therapy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004146
- Sponsor's protocol ID
- NCI-2012-03011
- Other IDs
- NCI-2012-03011, CDR67378, NABTT-9904, NABTT-9904, U01CA062475
- Status last verified
- Apr 2015
- First submitted
- 10 Dec 1999
- Last updated
- 8 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-Amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00004146
- Acronym / sponsor ID
- NCI-2012-03011
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2000
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Jun 2004 (estimated)
- Results
- Posted 8 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate overall survival rate in patients administered CAI (carboxyamidotriazole) and radiation therapy to adults with newly diagnosed glioblastoma multiforme.
II. To determine the toxicity of CAI when combined with cranial irradiation. III. To estimate correlations between pharmacokinetic parameters, including steady state CAI concentration, with toxicity and/or drug activity in this patient population.
IV. To estimate duration of disease free progression with this treatment regime.
OUTLINE: This is a multicenter study.
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (RT and CAI) | Experimental | Radiation: radiation therapy, Drug: carboxyamidotriazole, Other: pharmacological studyPatients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival. Other: pharmacological study, radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- Patients must have measurable or non-measurable tumor on the post operative, pretreatment MRI/CT scan (within two weeks of starting treatment)
- Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
- Patients must have recovered from the immediate post-operative period and be maintained on a stable steroid regimen (no increase for the last five days)
- Absolute neutrophil count >= 1500/mm^3
Key exclusion criteria (3 listed)
- Patients must be able to comply with prescribed medical care
- Prior therapy for the brain tumor (except surgery)
- Prior treatment with antineoplastic agents, including CAI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiotherapy | Radiation | Treatment (RT and CAI) |
| carboxyamidotriazoleAlso: CAI, carboxyamido-triazole, carboxyaminoimidazoleGiven orally | Drug | Treatment (RT and CAI) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (RT and CAI) |
Primary outcome
Overall Survival Rate
Time frame: approximately 30 months
estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death
Toxicity of CAI When Combined With RT
Time frame: pts were reviewed for toxicity while on treatement - median time of 2 months
patients who experienced a grade 3 or higher event considered at least possibly related to CAI
Correlation Between PK CAI and Toxicity in This pt Population
Time frame: during treatment
PK paramenters including steady state CAI concentrations with toxicity/or drug activity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Adult Giant Cell Glioblastoma
Active, not recruitingPhase 1
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Mikkelsen, MD principal investigator
New Approaches to Brain Tumor Therapy Consortium
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiation therapy, carboxyamidotriazole and pharmacological study in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival Rate (time frame: approximately 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.