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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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.

Study groups in NCT00352313
Study groupRoleWhat they receive
Phase IExperimentalPatients 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 IIExperimentalPatients 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.

  1. Safety

  2. Maximum tolerated dose (phase I)

  3. Progression-free survival at 6 months

  4. Response rate (phase I)

  5. Overall survival

Secondary outcomes (2)
  1. Efficacy

  2. 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.

  1. First posted14 Jul 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJan 2007
  4. Study completionJan 2008

Resources

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)
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

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.

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