NCT01740570

Brief Summary

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cabazitaxel that can be given to patients with glioblastoma. The goal of Part 2 is to learn if cabazitaxel can help to control glioblastoma. The safety of the study drug will also be studied in both parts. Cabazitaxel is designed to interfere with the growth of cancer cells by stopping cell division.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

4 years

First QC Date

November 30, 2012

Last Update Submit

January 17, 2018

Conditions

Brain Cancer

Keywords

Brain cancerMalignant gliomaGlioblastoma multiformeGliosarcomaAnaplastic astrocytomaAnaplastic oligodendrogliomaAnaplastic oligoastrocytomaCabazitaxelJevtana

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    The MTD of Cabazitaxel defined as the dose level at which no more than 1 out of 6 subjects experiences DLT. Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0. If multiple toxicities are seen, the presence of DLT should be based on the most severe toxicity experienced.

    3 weeks

Secondary Outcomes (1)

  • Progression Free Survival (PFS)

    6 months

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Cabazitaxel by vein on day 1 of each 3 week cycle. Phase I: Up to 5 dose levels of cabazitaxel tested. Two (2) dose levels will be given over 60 minutes, and 3 will be given over 30 minutes. First group of participants receive the lowest dose level. Each new group receives a higher dose level of cabazitaxel than the group before it, if no intolerable side effects were seen. Phase II: Cabazitaxel at the highest dose that was tolerated in Phase I.

Drug: Cabazitaxel

Interventions

CabazitaxelDRUG

Phase I Starting Dose: Cohort 1A) 25 mg/m2 by vein over 1 hour every 3 weeks. Cohort 1B) 20 mg/m2 by vein over 30 minutes every 3 weeks. Phase II: Maximum tolerated dose from Phase I.

Also known as: Jevtana
Cabazitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (\>/=18 years of age)
  • Karnofsky performance score \>/=60
  • Histologically proven WHO grade III and IV malignant gliomas for phase I of the study and supratentorial WHO grade IV malignant glioma (GBM and gliosarcoma) for Phase II.
  • Unequivocal evidence for tumor recurrence or progression by MRI scan.
  • For the phase I portion of the study, any number of prior relapses is permitted, provided all other eligibility criteria are met.
  • For the phase II portion of the study, no more than 2 prior relapses are allowed.
  • Must have failed prior chemo-radiation therapy and must be \>/=12 weeks from completion of the chemo-radiation therapy, unless tumor progression has been confirmed by either surgery or by appropriate imaging studies (e.g. PET scan, MR spectroscopy, etc.).
  • Baseline on-study MRI within 14 days prior to registration on stable or decreasing dose of steroids. If the steroid dose is increased between the date of imaging and the initiation of therapy (or at that time), a new baseline MRI is required.
  • Must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agents, 4 weeks from cytotoxic agents, two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, 3 weeks from bevacizumab (phase I only) and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, cis-retinoic acid, cytostatic agents such as signal transduction inhibitors etc given prior to trial entry as a non-investigational agent etc. (radiosensitizer does not count), at least 2 weeks from prior surgery.
  • Acceptable lab values including absolute neutrophil count \>/= 1,500/mm3 , Hemoglobin \>/= 8.0 g/dl, Platelet count \>/= 100,000/mm3, total bilirubin \</= upper limit of normal (ULN), AST (SGOT) \</= 1.5 x ULN, ALT (SGPT) \</= 1.5 x ULN and Creatinine \</= 1.5 x ULN.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 14 days prior to initiation of therapy.
  • Men and women of childbearing potential must be willing to consent to practice abstinence or using effective contraception while on treatment and for at least 1 month thereafter.
  • No prior malignancies for \>/= 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast.
  • Must provide informed consent prior to protocol specific procedures.
  • Prior bevacizumab allowed in phase I (washout period of 3 weeks necessary from the last dose).

You may not qualify if:

  • Any serious medical condition or laboratory abnormality which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. These would include active infection (including persistent fever), diseases or conditions that obscure toxicity or dangerously alter drug metabolism, serious intercurrent medical illness (e.g. symptomatic congestive heart failure).
  • Any serious medical condition or psychiatric illness that would prevent the subject from providing informed consent.
  • Females who are pregnant or breast feeding.
  • Known hypersensitivity to cabazitaxel or to polysorbate 80 (Prior cabazitaxel allowed if used \>3 yr for other malignancies and tolerated well).
  • Prior bevacizumab not allowed for phase II.
  • Concurrent use of other anti-cancer agents or treatments.
  • Patients must not be on enzyme inducing anticonvulsants (EIAED) due to its potential influence on cabazitaxel pharmacology; if the treating physician elects to change the medication to a non-enzyme inducing agent, a 1-week wash out period will be required after stopping EIAED prior to initiation of cabazitaxel.
  • Unable or unwilling to follow study requirements and schedule
  • CYP3A inducing or inhibiting drugs are not permitted. Hepatic enzyme inducing antiepileptic drugs are also hence not permitted while on study. A one-week wash out period after discontinuing such drugs is required prior to initiating treatment with Cabazitaxel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Brain NeoplasmsGliomaGlioblastomaGliosarcomaAstrocytomaOligodendroglioma

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Vinay K. Puduvalli, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

April 1, 2013

Primary Completion

April 1, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01