Dose-Intense Temozolomide in Recurrent Glioblastoma
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00657267 |
Recruitment Status :
Completed
First Posted : April 14, 2008
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Gliosarcoma | Drug: Temozolomide | Phase 2 |
- Participants will be given a medication-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks (28 days) during which time they will be taking temozolomide orally once a day for the first three weeks.
- At the end of each cycle (day 28, +/- 2 days), the following procedures will be performed: Complete physical examination including a neurological exam; vital signs; a review of current medications and symptoms; blood samples; a pregnancy test for women of child-bearing potential; self-administered quality of life questionnaire; brain MRI or CT scan.
- Participants may continue taking temozolomide until their tumor grows or if they experience unacceptable side effects.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 58 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Study of Dose-Intense Temozolomide in Recurrent Glioblastoma |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Single-Arm Study |
Drug: Temozolomide
Taken orally daily for the first three weeks of a four-week cycle.
Other Name: Temodar |
- 6 Month Progression Free Survival [ Time Frame: 6 months ]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).
- Overall Survival [ Time Frame: From patient registration until end of study, assessed up to 54 months ]
- Radiographic Response [ Time Frame: From patient registration until end of study, assessed up to 54 months ]Responders on study are those with a best response of either CR or PR. Per Modified Macdonald Criteria for lesions assessed by MRI/CT: Complete Response (CR) = Complete disappearance of all measurable and evaluable disease, no new lesions, no evidence of non-evaluable disease, with no steroids. Partial Response (PR) >/= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, no new lesions, with steroid dose @ time of response </= max dose w/in the first 8 weeks of therapy.
- Time to Progression. [ Time Frame: From patient registration until end of study, assessed up to 54 months ]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).

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must provide independent consent or must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- 18 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
- Participants who have undergone recent resection of recurrent or progressive tumor will be eligible provided at least 2 weeks has elapsed since surgery, and subjects have recovered from surgical-related trauma
- Residual disease following resection of recurrent GBM or gliosarcoma is not mandated for eligibility into the study.
Exclusion Criteria:
- 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

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 ClinicalTrials.gov identifier (NCT number): NCT00657267
United States, Massachusetts | |
Tufts Medical Center | |
Boston, Massachusetts, United States, 02111 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 | |
United States, North Carolina | |
Wake Forest Univsersity | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Pennsylvania | |
University Of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Patrick Wen, MD | Dana-Farber Cancer Institute |
Responsible Party: | Patrick Y. Wen, MD, Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00657267 History of Changes |
Other Study ID Numbers: |
08-013 P05516 ( Other Identifier: Schering Plough ) |
First Posted: | April 14, 2008 Key Record Dates |
Results First Posted: | March 14, 2014 |
Last Update Posted: | March 14, 2014 |
Last Verified: | February 2014 |
Keywords provided by Patrick Y. Wen, MD, Dana-Farber Cancer Institute:
recurrent glioblastoma temodar temozolomide |
Additional relevant MeSH terms:
Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |