Dose-Intense Temozolomide in Recurrent Glioblastoma

NCT00657267 | Completed Phase 2 Results DMC

• 2 other identifiers: 08-013P05516
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 6

Brief Summary

Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is to determine if patients that have failed standard temozolomide treatment will respond to temozolomide when given at a different dose and schedule (21 days every 28 days).

Conditions

Glioblastoma; Gliosarcoma

Keywords

recurrent glioblastoma; temodar; temozolomide

Outcome Measures

Primary Outcomes (1)

• 6 Month Progression Free Survival

  Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

  6 months

Secondary Outcomes (3)

• Overall Survival

  From patient registration until end of study, assessed up to 54 months

• Radiographic Response

  From patient registration until end of study, assessed up to 54 months

• Time to Progression.

  From patient registration until end of study, assessed up to 54 months

Study Arms (1)

Single-Arm Study

EXPERIMENTAL

Drug: Temozolomide

Interventions

Temozolomide DRUG

Taken orally daily for the first three weeks of a four-week cycle.

Also known as: Temodar

Single-Arm Study

Eligibility Criteria

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

You may qualify if:

• Must provide independent consent or must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
• years of age or older (of either sex, and of any race)
• Histologic diagnosis of GBM or gliosarcoma with an unequivocal progression by MRI or CT scan
• Must have received standard combined modality therapy as first-line treatment consisting of RT plus concomitant temozolomide followed by adjuvant temozolomide (at least 2 cycles of adjuvant temozolomide)
• Gadolinium MRI or contrast CT scan must be obtained within 14 days prior to registration, and must be on a steroid dose that has been stable for at least 5 days.
• Karnofsky Performance status of 60 or greater
• Life expectancy of at least 8 weeks
• Recovered from the toxic effects of prior therapy, and 21 days must have elapsed since prior treatment with temozolomide
• o If a patient has residual toxicity from any previous treatment, toxicity must be ≤ Grade 1
• Laboratory tests within parameters outlined in the protocol
• Female subjects of childbearing potential \& male subjects with female partner of childbearing potential must agree to use a medically accepted method of contraception or be surgically sterilized prior to Screening, while receiving protocol-specified medication, and for 30 days after stopping the study medication
• Negative pregnancy test within 48 hours prior to dosing with the study drug (for female subjects of childbearing potential)
• Free of any clinically relevant disease that would, in the Principal Investigator's opinion, interfere with the conduct of the study or study evaluations
• Must be able to adhere to the dosing and visit schedules, and agree to record medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary
• Unstained slides (at least 15 of 10 micron thickness, or 20 when \< 10 micron thickness)or 1 tissue block must be available from the original diagnostic biopsy/surgery or from the biopsy/surgery recurrence

You may not qualify if:

• Participant has received a dosing schedule of temozolomide other than 75 mg/m2/day for 42 days during RT followed by adjuvant temozolomide at a dose of 150-200 mg/m2/day for 5 days of a 28-day schedule (standard dose adjustments for toxicity are allowed)
• Any other anti-tumor agent other than standard surgical resection, RT and temozolomide prior to enrollment or during the study period
• Received treatment with BCNU (Gliadel) wafers or GliaSite
• Progressed prior to receiving at least 2 cycles of adjuvant temozolomide
• Pregnant or intending to become pregnant during the study
• In a situation or condition that, in the opinion of the Investigator, may interfere with optimal participation in the study
• Participating in any other clinical study in which an investigational drug is prescribed
• Allergic to or has sensitivity to the study drug or its excipients
• History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless he/she is in complete remission and has not received treatment for that particular disease for the past 3 or more years

Sponsors & Collaborators

• Patrick Y. Wen, MD: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• University of Pennsylvania: collaborator
• Wake Forest University Health Sciences: collaborator
• Tufts Medical Center: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Schering-Plough: collaborator

Study Sites (6)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Wake Forest Univsersity

Winston-Salem, North Carolina, 27157, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Patrick Y. Wen, MD
• Organization: Dana-Farber Cancer Institute / Brigham & Women's Hospital

pwen@partners.org

617-632-2166

Study Officials

• Patrick Wen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: October 1, 2013
• Last Updated: March 14, 2014
• Results First Posted: March 14, 2014

Record last verified: 2014-02

Locations

US (6)