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Brain and Central Nervous System TumorsPhase 1/2NCT00047073

Sirolimus in Treating Patients With Glioblastoma Multiforme

A Phase 1/2 study testing Rapamycin, Surgery and Supportive Care in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center 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: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. 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?
Rapamycin, Surgery and Supportive Care
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Jul 2002to Oct 2007
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 confirmed intracranial glioblastoma multiforme
  • Disease progression by MRI or CT scan
  • Confirmation of true progressive disease (not radiation necrosis) by positron-emission tomography, thallium scanning, MRI, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery
  • Failed prior radiotherapy
  • Phase I patients:
  • Eligible for salvage surgery
  • No limits on prior therapy
  • Phase II patients:
  • Tumor progression by MRI or CT scan required within the past 14 days if recurrent disease is present
  • No prior therapy for more than 3 relapses
  • Recent resection of recurrent or progressive tumor allowed as long as all of the following conditions apply:
  • Recovered from surgery
  • MRI or CT scan performed no more than 96 hours since prior surgery OR within 4-6 weeks after surgery
  • Baseline MRI or CT scan performed within 14 days of study entry

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 8 weeks

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT less than 1.5 times ULN

Renal

  • Creatinine less than 1.5 mg/dL

Other

  • Cholesterol less than 350 mg/dL
  • Triglycerides less than 400 mg/dL
  • No concurrent disease that would obscure toxicity or dangerously alter drug metabolism
  • No other significant uncontrolled serious medical illness that would preclude study participation
  • No other cancer except non-melanoma skin cancer or carcinoma in situ of the cervix unless patient is in complete remission and off all therapy for that disease for at least 3 years
  • No active infection
  • No prior allergic reactions to compounds of similar chemical or biological composition to sirolimus
  • No psychiatric illness that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 1 week since prior interferon

Chemotherapy

  • At least 2 weeks since prior vincristine
  • At least 3 weeks since prior procarbazine
  • At least 6 weeks since prior nitrosoureas

Endocrine therapy

  • At least 1 week since prior tamoxifen

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Recovered from prior therapy
  • At least 1 week since prior noncytotoxic agents (except radiosensitizers)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme

RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who have glioblastoma multiforme that did not respond to previous radiation therapy.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of sirolimus in patients with glioblastoma multiforme.
  • Determine the safety profile of this drug in these patients.
  • Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective response, in these patients.

OUTLINE: This is a dose-escalation study.

  • Phase I: Patients receive oral sirolimus for 5-7 days before surgery. Patients then undergo surgical resection. Patients resume oral sirolimus once daily after full recovery from surgery. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

  • Phase II: Patients receive oral sirolimus as in phase I at the dose determined in that phase.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for phase I of the study within 3-12 months. A total of 32 patients will be accrued for phase II of the study.

Being tested
Rapamycin, Surgery, Supportive Care
Keywords
recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

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

  • RapamycinDrug

    Also called Sirolimus

    Phase 1: Initial dose 6mg on day 1 and then 2mg each day for 5-7 days before surgery. No dosing during surgery recovery. After recorvery 6mg loading dose on day 1 then 2mg each day. Cycle is every 4 weeks.

    Dose escalation: Level 2: 15mg load/5mg/day, Level 3: 30mg load/10mg/day, Level 4: 45mg load/15mg/day.

    Phase 2: Will utilize dose established in phase I. Dosing schedule will remain the same.

  • SurgeryProcedure or surgery

    Surgical resection.

  • Supportive CareProcedure or surgery

    Corticosteroids should be used in smallest dose to control symptoms of cerebral edema and mass effect.

    Anti-seizure medications should be used as indicated. Febrile neutropenia may be managed according to local institution's infectious disease guidelines.

    If neurosurgical management is required for reasons not due to tumor progression, these procedures must be documented.

Study groups in NCT00047073
Study groupRoleWhat they receive
Phase 1ExperimentalSee intervention description.
Receives: Drug: Rapamycin; Procedure: Surgery; Procedure: Supportive Care
Phase 2ExperimentalSee intervention description.
Receives: Drug: Rapamycin; Procedure: Surgery; Procedure: Supportive Care

What is being measured

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

  1. Maximum tolerated dose (for phase 1)

    Measured: end of phase 1

  2. Efficacy in terms of progression-free survival at 6 months and objective response (phase II)

    Measured: 6 months after last subject finishes trial

Secondary outcomes (2)

  1. Safety Profile (phase I)

    Measured: end of phase I

  2. Further evaluate safety profile

    Measured: end of 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 posted27 Jan 2003 (estimated)
  2. Study startJul 2002
  3. Primary completionJun 2005
  4. Study completionOct 2007

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047073
Sponsor's protocol ID
CDR0000257255
Other IDs
UCLA-0203078, NCI-G02-2114
Status last verified
Jul 2012
First submitted
3 Oct 2002
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Cloughesy TF, Yoshimoto K, Nghiemphu P, Brown K, Dang J, Zhu S, Hsueh T, Chen Y, Wang W, Youngkin D, Liau L, Martin N, Becker D, Bergsneider M, Lai A, Green R, Oglesby T, Koleto M, Trent J, Horvath S, Mischel PS, Mellinghoff IK, Sawyers CL. Antitumor activity of rapamycin in a Phase I trial for patients with recurrent PTEN-deficient glioblastoma. PLoS Med. 2008 Jan 22;5(1):e8. doi: 10.1371/journal.pmed.0050008.

    PubMed 18215105

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rapamycin, Surgery and Supportive Care in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center 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 3 Aug 2020. 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 (for phase 1) (time frame: end of phase 1). 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 NCT00047073, which also lists 1 linked publication.

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 3 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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