Temozolomide in Treating Patients With Recurrent High-Grade Glioma

NCT00619112 | Completed Phase 2 Results DMC

• 2 other identifiers: UCSF-07107SPRI-UCSF-H44867-31182-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.

Conditions

Recurrent Central Nervous System Neoplasm

Keywords

adult glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; recurrent adult brain tumor

Outcome Measures

Primary Outcomes (1)

• 6 Month Progression-free Survival

  Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival

  First day of treatment until progression or until 6 months mark

Secondary Outcomes (6)

• Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.

  First day of treatment until progression or until 6 months mark

• Overall Survival

  up to 2 years after treatment

• Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System

  prior to start of study

• Patients Progressing After Two First-line Adjuvant Courses of Temozolomide

  After two first-line adjuvant courses of temozolomide

• Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide

  Within 6 months after 6th adjuvant course of temozolomide

Study Arms (1)

Temozolomide

EXPERIMENTAL

single arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14

Drug: temozolomide

Interventions

temozolomide DRUG

single arm study

Also known as: temodar

Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiographically proven recurrent, intracranial malignant glioma will be eligible for this protocol.
• All patients must sign an informed consent
• Patients must have had external beam radiation; there is no limit to the number of prior chemotherapies used.
• Patients must be \> 18 years old, and with a life expectancy \> 8 weeks.
• Patients must have a Karnofsky performance status of \> 60.
• At the time of registration: Patients must have recovered from the toxic effects of prior therapy:
• Patients must have adequate bone marrow function.
• Patients must have shown unequivocal radiographic evidence for tumor progression by MRI
• Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: They have recovered from the effects of surgery. Residual disease following resection of recurrent intracranial malignant glioma is not mandated for eligibility into the study.
• Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry.
• Patients with prior therapy that included interstitial brachytherapy, stereotactic radiosurgery, or Gliadel wafers must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or MR spectroscopy or surgical documentation of disease.
• Male and female patients with reproductive potential must use an approved contraceptive method

You may not qualify if:

• Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
• Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
• Patients must not have active infection or serious intercurrent medical illness.
• Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Han SJ, Rolston JD, Molinaro AM, Clarke JL, Prados MD, Chang SM, Berger MS, DeSilva A, Butowski NA. Phase II trial of 7 days on/7 days off temozolmide for recurrent high-grade glioma. Neuro Oncol. 2014 Sep;16(9):1255-62. doi: 10.1093/neuonc/nou044. Epub 2014 Mar 26.

  PMID: 24670608 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma; Astrocytoma; Oligodendroglioma; Glioma; Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The trial reached enrollment. There were no unexpected toxicities.

Results Point of Contact

• Title: Nicholas Butowski
• Organization: UCSF

Butowski@neurosurg.ucsf.edu

4153532966

Study Officials

• Nicholas A. Butowski, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Susan M. Chang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 20, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: January 31, 2018
• Results First Posted: October 29, 2013

Record last verified: 2018-01

Locations

US (1)