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Brain and Central Nervous System TumorsPhase 1/2NCT00003616

Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma

A Phase 1/2 study testing irinotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 10 sites 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. PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients who have progressive or recurrent malignant glioma. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
irinotecan hydrochloride
How many people
Not given
Where
10 sitesUnited States
Study dates
22 Oct 1998to 20 Dec 2005
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Histologically proven progressive or recurrent primary malignant glioma Phase I (excluding group A patients): No more than 2 prior chemotherapy regimens, including 1 prior adjuvant therapy and 1 prior regimen for recurrent or progressive tumor, or 2 prior regimens for progressive tumor Phase II and/or group A patients: No more than 1 prior chemotherapy regimen, either as adjuvant or for recurrent disease Measurable disease by MRI or CT scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled hypertension No unstable angina No symptomatic congestive heart failure No myocardial infarction within 6 months No serious uncontrolled cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No severe nonmalignant systemic disease or active infection No concurrent alcoholism or drug abuse No psychosis HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or suramin) No prior irinotecan, topotecan, or other topotecan 1 inhibitors No other concurrent chemotherapy Endocrine therapy: Stable or decreasing dosage of corticosteroids within 72 hours of study entry (phase II only) No other concurrent immunosuppressive agents No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of progressive disease No concurrent radiotherapy Surgery: At least 3 weeks since prior resection Other: Acute toxic effects (excluding neurotoxicity or alopecia) of any prior therapy must be resolved No concurrent valproic acid as a single agent Concurrent enzyme-inducing antiepileptic drugs (EIAED) with or without steroids are allowed No concurrent investigational drugs

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

Other trials in United States

About this study

Official title: Phase I/II Trial of Irinotecan (CPT-11) in Patients With Recurrent Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients who have progressive or recurrent malignant glioma.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of irinotecan in patients with progressive or recurrent malignant glioma. II. Define the safety profile of every 3 week dosing of irinotecan in these patients. III. Characterize the pharmacokinetic profile of this regimen in these patients. IV. Assess evidence of antitumor activity in these patients. V. Determine the efficacy of irinotecan in these patients as measured by 6 month progression-free survival and objective tumor response. VI. Evaluate further the safety profile of irinotecan in these patients during phase II study.

OUTLINE: This is a dose escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (EIAEDs)(yes vs no). Group A (without EIAEDs): Patients receive irinotecan IV over 90 minutes on day 1, followed by up to 3 weeks of rest. Group B (with EIAEDs): Patients receive the same treatment but dose escalation is performed in cohorts of 3 patients. The maximum tolerated dose (MTD) is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicities. The Phase I MTD is the starting dose recommended for use in the Phase II portion of the study. Treatment continues every 3 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months until disease progression. Patients are then followed every 4 months for survival.

PROJECTED ACCRUAL: Up to 30 patients will be accrued for phase I within 10 months. A total of 48 patients will be accrued for phase II within 6-8 months.

Keywords
recurrent adult brain tumor, adult brain stem glioma, adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Oligodendroglioma, Glioma, Astrocytoma

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 posted9 Feb 2004 (estimated)
  2. Study start22 Oct 1998
  3. Primary completion17 May 2002
  4. Study completion20 Dec 2005

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003616
Sponsor's protocol ID
NABTC-9801
Other IDs
CDR0000066694
Status last verified
Jun 2018
First submitted
1 Nov 1999
Last updated
27 Jun 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Prados MD, Lamborn K, Yung WK, Jaeckle K, Robins HI, Mehta M, Fine HA, Wen PY, Cloughesy T, Chang S, Nicholas MK, Schiff D, Greenberg H, Junck L, Fink K, Hess K, Kuhn J; North American Brain Tumor Consortium. A phase 2 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: a North American Brain Tumor Consortium study. Neuro Oncol. 2006 Apr;8(2):189-93. doi: 10.1215/15228517-2005-010. Epub 2006 Mar 13.

    PubMed 16533878

  • Prados MD, Yung WK, Jaeckle KA, Robins HI, Mehta MP, Fine HA, Wen PY, Cloughesy TF, Chang SM, Nicholas MK, Schiff D, Greenberg HS, Junck L, Fink KL, Hess KR, Kuhn J; North American Brain Tumor Consortium study. Phase 1 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: a North American Brain Tumor Consortium study. Neuro Oncol. 2004 Jan;6(1):44-54. doi: 10.1215/S1152851703000292.

    PubMed 14769140

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing irinotecan hydrochloride in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 10 sites 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003616, which also lists 2 linked publications.

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 27 Jun 2018.

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