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Phase I/II Cabazitaxel for Recurrent Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01740570
Recruitment Status : Withdrawn
First Posted : December 4, 2012
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Brain Cancer Drug: Cabazitaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Cabazitaxel in Adult Patients With Recurrent Malignant Glioma
Study Start Date : April 2013
Estimated Primary Completion Date : April 2017

Arm Intervention/treatment
Experimental: Cabazitaxel

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

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.

Other Name: Jevtana

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 3 weeks ]
    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.

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 6 months ]
    The primary endpoint is progression within 6 months. Distributions of time to progression or death (PFS), and time to death estimated using the Kaplan-Meier method.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adults (>/=18 years of age)
  2. Karnofsky performance score >/=60
  3. 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.
  4. Unequivocal evidence for tumor recurrence or progression by MRI scan.
  5. For the phase I portion of the study, any number of prior relapses is permitted, provided all other eligibility criteria are met.
  6. For the phase II portion of the study, no more than 2 prior relapses are allowed.
  7. 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.).
  8. 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.
  9. 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.
  10. 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.
  11. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 14 days prior to initiation of therapy.
  12. 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.
  13. 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.
  14. Must provide informed consent prior to protocol specific procedures.
  15. Prior bevacizumab allowed in phase I (washout period of 3 weeks necessary from the last dose).

Exclusion Criteria:

  1. 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).
  2. Any serious medical condition or psychiatric illness that would prevent the subject from providing informed consent.
  3. Females who are pregnant or breast feeding.
  4. Known hypersensitivity to cabazitaxel or to polysorbate 80 (Prior cabazitaxel allowed if used >3 yr for other malignancies and tolerated well).
  5. Prior bevacizumab not allowed for phase II.
  6. Concurrent use of other anti-cancer agents or treatments.
  7. 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.
  8. Unable or unwilling to follow study requirements and schedule
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01740570

Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Vinay K. Puduvalli, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01740570    
Other Study ID Numbers: 2012-0228
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Keywords provided by M.D. Anderson Cancer Center:
Brain cancer
Malignant glioma
Glioblastoma multiforme
Anaplastic astrocytoma
Anaplastic oligodendroglioma
Anaplastic oligoastrocytoma
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases