Brain and Central Nervous System TumorsPhase 1/2NCT00352313
ATN-161 and Carboplatin in Treating Patients With Recurrent Malignant Glioma
A Phase 1/2 study testing ATN-161 and carboplatin in people with Brain and Central Nervous System Tumors, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- ATN-161 and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2008
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed intracranial malignant glioma
- Original low-grade glioma histology allowed provided there is subsequent histologic confirmation of malignant glioma
- Any of the following diagnoses:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant astrocytoma not otherwise specified
- Recurrent disease
- Must have failed prior radiotherapy
- Must have confirmation of true progressive disease (rather than radiation necrosis) based upon either positron emission tomography or thallium scanning, MR spectroscopy, or surgical documentation of disease if radiographic recurrence is within the high-dose radiation field (for patients who underwent prior interstitial brachytherapy or stereotactic radiosurgery)
- Prior recent resection of recurrent or progressive tumors allowed if all of the following criteria are met:
- Recovered from prior surgery
- Evaluable disease after resection
- Unequivocal evidence of tumor progression by MRI
- Steroid dose must be stable for ≥ 5 days prior to MRI
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy > 8 weeks
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- AST < 2.5 times upper limit of normal (ULN)
- Bilirubin < 2.5 times ULN
- Creatinine < 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after completion of study treatment
- No significant medical illness that would preclude study treatment
- No history of other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless disease is in complete remission and off all therapy for ≥ 1 year
- No active infection or serious intercurrent medical illness
- No disease that will obscure toxicity or dangerously alter drug metabolism
- Able to undergo MRI scan and receive contrast agents for perfusion scanning
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 28 days since prior cytotoxic therapy
- At least 14 days since prior vincristine
- At least 42 days since prior nitrosoureas
- At least 21 days since prior procarbazine
- At least 7 days since prior interferon, tamoxifen, thalidomide, isotretinoin, or other noncytotoxic agents (radiosensitizer does not count)
- At least 14 days since prior noncytotoxic investigational agents
- At least 42 days since prior radiotherapy
- No prior cisplatin, carboplatin, oxaliplatin, or platinum-containing analogue
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- No other concurrent anticancer therapy (including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy)
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: A Phase I/II Study of ATN-161 and Carboplatin in Adult Patients With Recurrent Intracranial Malignant Glioma
RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161 together with carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when given together with carboplatin and to see how well they work in treating patients with recurrent malignant glioma.
Read the detailed description
OBJECTIVES:
Primary
- Establish the safety of ATN-161 and carboplatin in patients with recurrent intracranial malignant glioma.
- Determine the maximum tolerated dose of ATN-161 when administered with carboplatin in these patients. (phase I)
- Determine the antitumor activity of ATN-161 when administered with carboplatin in these patients. (phase II)
Secondary
- Describe the effects of this regimen on potential biomarkers of activity, including functional imaging with brain perfusion scans and circulating endothelial progenitor cells.
- Obtain preliminary evidence of efficacy of this regimen in these patients. (phase I)
- Characterize the plasma concentrations of this regimen in these patients. (phase I)
OUTLINE: This is an open-label, phase I dose-escalation study of ATN-161 followed by a phase II study. Patients in the phase II portion of the study are stratified according to tumor type (glioblastoma multiforme vs anaplastic glioma).
- Phase I: Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ATN-161 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 during the first 6 weeks of treatment.
- Phase II: Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline and then periodically during phase I course 1 for pharmacokinetic and pharmacodynamic analysis and at baseline and then periodically during study for biomarker (e.g., circulating endothelial progenitor cells) correlative studies.
After completion of study treatment, patients are followed for 28 days.
PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- ATN-161, carboplatin
- Keywords
- adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Oligodendroglioma, Gliosarcoma, Glioma, Astrocytoma, Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATN-161Drug
Given IV
carboplatinDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: ATN-161; Drug: carboplatin |
| Phase II | Experimental | Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: ATN-161; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Maximum tolerated dose (phase I)
Progression-free survival at 6 months
Response rate (phase I)
Overall survival
Secondary outcomes (2)
Efficacy
Response rate (phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2007
- Study completionJan 2008
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.
- 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 1/2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Howard A. Fine, MD, Principal investigator, NCI - Neuro-Oncology Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352313
- Sponsor's protocol ID
- 060170
- Other IDs
- 06-C-0170, NCI-P6790, ATN-161-002, CDR0000487605
- Status last verified
- May 2012
- First submitted
- 13 Jul 2006
- Last updated
- 2 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of ATN-161 and Carboplatin in Adult Patients With Recurrent Intracranial Malignant Glioma
- ClinicalTrials.gov ID
- NCT00352313
- Acronym / sponsor ID
- 060170
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Jul 2006 (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: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161 together with carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when given together with carboplatin and to see how well they work in treating patients with recurrent malignant glioma.
Detailed description
OBJECTIVES:
Primary
- Establish the safety of ATN-161 and carboplatin in patients with recurrent intracranial malignant glioma.
- Determine the maximum tolerated dose of ATN-161 when administered with carboplatin in these patients. (phase I)
- Determine the antitumor activity of ATN-161 when administered with carboplatin in these patients. (phase II)
Secondary
- Describe the effects of this regimen on potential biomarkers of activity, including functional imaging with brain perfusion scans and circulating endothelial progenitor cells.
- Obtain preliminary evidence of efficacy of this regimen in these patients. (phase I)
- Characterize the plasma concentrations of this regimen in these patients. (phase I)
OUTLINE: This is an open-label, phase I dose-escalation study of ATN-161 followed by a phase II study. Patients in the phase II portion of the study are stratified according to tumor type (glioblastoma multiforme vs anaplastic glioma).
- Phase I: Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ATN-161 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 during the first 6 weeks of treatment.
- Phase II: Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline and then periodically during phase I course 1 for pharmacokinetic and pharmacodynamic analysis and at baseline and then periodically during study for biomarker (e.g., circulating endothelial progenitor cells) correlative studies.
After completion of study treatment, patients are followed for 28 days.
PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: ATN-161, Drug: carboplatinPatients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. |
| Phase II | Experimental | Drug: ATN-161, Drug: carboplatinPatients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| ATN-161Given IV | Drug | Phase I, Phase II |
| carboplatinGiven IV | Drug | Phase I, Phase II |
Primary outcome
Safety
Maximum tolerated dose (phase I)
Progression-free survival at 6 months
Response rate (phase I)
Overall survival
2 secondary outcomes
Efficacy
Response rate (phase II)
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 2 May 2012.
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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.
Howard A. Fine, MD principal investigator
NCI - Neuro-Oncology Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATN-161 and carboplatin in people with Brain and Central Nervous System Tumors, run by National Institutes of Health Clinical Center (CC) 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 2 May 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Safety. The study lists 5 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 2 May 2012.