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Brain and Central Nervous System TumorsPhase 2NCT00010036

Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

A Phase 2 study testing carboplatin, irinotecan hydrochloride and radiation therapy in people with Brain and Central Nervous System Tumors, run by NYU Langone Health 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma… 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?
carboplatin, irinotecan hydrochloride and radiation therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
May 1999to Oct 2001
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme
  • Measurable disease
  • No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement)
  • No known Gilbert's syndrome

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring therapy

Other:

  • HIV negative
  • No active or uncontrolled infection
  • No psychiatric disorder that would preclude study
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more)
  • No other severe disease that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy or biologic therapy
  • No concurrent sargramostim (GM-CSF)
  • No concurrent filgrastim (G-CSF) with course 1
  • No concurrent immunotherapy

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior to study
  • Concurrent corticosteroids for cerebral edema allowed
  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • No prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks since prior surgery

Other:

  • No other concurrent investigational agent or participation on any other clinical study
  • No concurrent immunosuppressive drugs
  • No concurrent phenobarbital or valproic acid
  • No concurrent anticonvulsants except carbamazepine or gabapentin
  • No concurrent prochlorperazine on day of irinotecan treatment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

Other trials in United States

About this study

Official title: A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients with glioblastoma multiforme. (Phase I closed to accrual as of 6/24/02)
  • Determine the toxic effects of this regimen in these patients.
  • Determine the objective response in patients treated with the established MTD of this regimen.
  • Determine time to tumor progression and survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are stratified according to age (under 60 vs 60 and over), ECOG performance status (0-1 vs 2), and extent of resection (total vs subtotal). (Phase I closed to accrual as of 6/24/02)

Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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. Once the MTD is determined, additional patients are accrued to receive carboplatin and irinotecan at the recommended phase II dose. (Phase I closed to accrual as of 6/24/02)

After chemotherapy, all patients undergo radiotherapy.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will be accrued for this study. (Phase I closed to accrual as of 6/24/02)

Being tested
carboplatin, irinotecan hydrochloride, radiation therapy
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2003 (estimated)
  2. Study startMay 1999
  3. Primary completionOct 2001

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 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00010036
Sponsor's protocol ID
CDR0000068435
Other IDs
P30CA016087, NYU-9902, P-UPJOHN-986475197, NCI-G00-1909
Status last verified
Mar 2011
First submitted
2 Feb 2001
Last updated
28 Mar 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, irinotecan hydrochloride and radiation therapy in people with Brain and Central Nervous System Tumors, run by NYU Langone Health 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 28 Mar 2011. 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 28 Mar 2011.

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