Brain and Central Nervous System TumorsPhase 2NCT00002639
Suramin in Treating Patients With Recurrent Primary Brain Tumors
A Phase 2 study testing chemotherapy and suramin in people with Brain and Central Nervous System Tumors, run by Emory University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with recurrent primary brain tumors following radiation therapy. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- chemotherapy and suramin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 1995to May 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Recurrent brain tumor based on one of the following: Tissue diagnosis if there was a prior diagnosis of astrocytoma or oligodendroglioma or if there is a question of radiation necrosis from prior interstitial brachytherapy Metabolic activity in excess of normal cortex measured by 18-fluorodeoxyglucose uptake on PET One of the following histologic types required: Glioblastoma multiforme Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed glioma Tumor progression required, i.e.: 28% increase in contrast-enhancing area or 50% increase in contrast- enhancing volume over at least 4 weeks Measurable disease required No history, surgical findings, or radiographic signs of intratumoral hemorrhage
PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Karnofsky 50%-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 3 times normal No history of bleeding disorder No hepatic disease resulting in hospitalization Renal: Creatinine less than 1.5 mg/dL No renal disease resulting in hospitalization Cardiovascular: No ongoing anticoagulation for deep vein thrombosis (DVT) No residual symptoms from DVT after discontinuation of anticoagulation No cardiac disease resulting in hospitalization Pulmonary: No pulmonary disease resulting in hospitalization Other: No peripheral neuropathy of any etiology HIV negative No pregnant or nursing women Adequate contraception required during and for 12 months following protocol therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for glioblastoma multiforme No more than 1 prior chemotherapy regimen for anaplastic astrocytoma, malignant oligodendroglioma, or malignant mixed glioma At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: Completion of 1 course of conventional external radiotherapy required At least 4 weeks since radiotherapy Surgery: Decompressive surgery for clinically suspected increased intracranial pressure performed prior to entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurosurgery - Emory
Atlanta, Georgia, 30322
About this study
Official title: ANALYSIS OF THE EFFICACY OF SURAMIN IN RECURRENT MALIGNANT PRIMARY BRAIN TUMORS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with recurrent primary brain tumors following radiation therapy.
Read the detailed description
OBJECTIVES: I. Estimate the efficacy of suramin in patients with recurrent primary brain tumors as measured by radiographic response, time to progression, and survival. II. Assess the toxic effects of suramin in this patient population.
OUTLINE: Single-Agent Chemotherapy. Suramin, SUR, NSC-34936.
PROJECTED ACCRUAL: If at least 1 of the first 14 patients experiences at least a partial response, a total of 25 patients will be entered over approximately 30 months.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- chemotherapy, suramin
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
suraminDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2004 (estimated)
- Study startJul 1995
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jeffrey J. Olson, MD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002639
- Sponsor's protocol ID
- CDR0000064118
- Other IDs
- EUC-DON-9420, NCI-T94-0033O
- Status last verified
- Feb 2001
- First submitted
- 1 Nov 1999
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALYSIS OF THE EFFICACY OF SURAMIN IN RECURRENT MALIGNANT PRIMARY BRAIN TUMORS
- ClinicalTrials.gov ID
- NCT00002639
- Acronym / sponsor ID
- CDR0000064118
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1995
- Study completion
- May 2004 (actual)
- First posted
- 26 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with recurrent primary brain tumors following radiation therapy.
Detailed description
OBJECTIVES: I. Estimate the efficacy of suramin in patients with recurrent primary brain tumors as measured by radiographic response, time to progression, and survival. II. Assess the toxic effects of suramin in this patient population.
OUTLINE: Single-Agent Chemotherapy. Suramin, SUR, NSC-34936.
PROJECTED ACCRUAL: If at least 1 of the first 14 patients experiences at least a partial response, a total of 25 patients will be entered over approximately 30 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| chemotherapy | Drug | – |
| suramin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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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.
Jeffrey J. Olson, MD study chair
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemotherapy and suramin in people with Brain and Central Nervous System Tumors, run by Emory University at 1 site 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?
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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 21 Jun 2013.