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Brain and Central Nervous System TumorsPhase 1/2NCT00389584

Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors

A Phase 1/2 study testing irinotecan hydrochloride, cognitive assessment and management of therapy complications in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by University of California, Davis 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: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor cells more sensitive to radiation therapy. Read more about this study

Who is it for?
Ages 1 year to 120 years
What is being tested?
irinotecan hydrochloride, cognitive assessment and management of therapy complications
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteUnited States
Study dates
Dec 2002to Nov 2006
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 1 year to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of brain metastasis from a histologically confirmed solid tumor, meeting the following criteria:
  • Must have histologic proof of original malignancy
  • No germ cell tumor metastasis
  • Biopsy-proven brain metastasis preferred when clinical history and radiographic findings are equivocal
  • At least 1 unidimensionally measurable lesion ≥ 50 mm by head contrast CT scan and/or brain MRI
  • Patients enrolled in the phase II portion of the study must meet the following Radiation Therapy Oncology Group Recursive Partitioning Analysis staging criteria for brain metastases:
  • Class II classification
  • Zubrod performance status 0-1 AND any of the following:
  • Age > 65 years
  • Extracranial metastasis
  • Uncontrolled primary malignancy

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Life expectancy ≥ 3 months
  • Able to participate in the Mini-Mental Status Examination
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Hemoglobin ≥ 9.0 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent medical disease that, in the investigator's opinion, would preclude study participation

PRIOR CONCURRENT THERAPY:

  • More than 21 days since prior chemotherapy
  • No prior whole-brain radiotherapy
  • No prior DNA topoisomerase I drugs (e.g., irinotecan hydrochloride, topotecan hydrochloride)
  • At least 4 days since prior and no concurrent known CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Hypericum perforatum (St. John's wort)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Phase I/II Study of Irinotecan and Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when given together with whole-brain radiation therapy and to see how well they work in treating patients with brain metastases from solid tumors. (The study of side effects and best dose has ended as of 4/15/05)

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of irinotecan hydrochloride administered concurrently with whole-brain radiotherapy in patients with brain metastases from solid tumors. (Phase I) (Phase I closed to accrual as of 4/15/05)
  • Determine the toxicity of this regimen in these patients. (Phase I) (Phase I closed to accrual as of 4/15/05)
  • Determine the overall survival of patients treated with this regimen. (Phase II)

Secondary

  • Assess the neurocognitive function of these patients by Mini-Mental Status Examination. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of irinotecan hydrochloride (phase I closed to accrual as of 4/15/05) followed by a phase II study. Patients enrolled in phase II are stratified according to cognitive dysfunction (yes vs no).

  • Phase I (closed to accrual as of 4/15/05): Patients undergo whole-brain radiotherapy (WBRT) once daily, 5 days a week, for 3 weeks (15 fractions). Patients also receive irinotecan hydrochloride IV over 90 minutes on days 1, 8, and 15.

Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II (for patients enrolled after 4/15/05): Patients receive irinotecan hydrochloride at the MTD and undergo concurrent WBRT as in phase I.

Patients complete the Mini-Mental Status Examination to assess neurocognitive function at baseline, on the last day of radiotherapy, and periodically after completion of study therapy.

After completion of study therapy, patients are followed monthly for 3 months, at 6 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.

Being tested
irinotecan hydrochloride, cognitive assessment, management of therapy complications, radiation therapy
Keywords
cognitive/functional effects, poor performance status, long-term effects secondary to cancer therapy in adults, long-term effects secondary to cancer therapy in children, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • irinotecan hydrochlorideDrug

  • cognitive assessmentProcedure or surgery

  • management of therapy complicationsProcedure or surgery

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05)

  2. Overall survival (Phase II)

Secondary outcomes (2)

  1. Neurocognitive deterioration as assessed by Mini-Mental Status Examination (Phase II)

  2. Time to cognitive failure as assessed by Kaplan-Meier (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 posted19 Oct 2006 (estimated)
  2. Study startDec 2002
  3. Primary completionNov 2006
  4. Study completionNov 2006

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
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389584
Sponsor's protocol ID
CDR0000506074
Other IDs
UCDCC-132, UCDCC-200210643-5, PFIZER-Z1001692
Status last verified
Oct 2017
First submitted
18 Oct 2006
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing irinotecan hydrochloride, cognitive assessment and management of therapy complications in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by University of California, Davis 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 6 Nov 2017. 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?

Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389584.

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 6 Nov 2017.

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