Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
Weill Medical College of Cornell University
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00498927
First received: July 10, 2007
Last updated: March 4, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 glioblastoma multiforme or other malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: temozolomide Genetic: protein expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunoenzyme technique |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Progression-free survival (PFS) rate at 6 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- PFS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 47 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Temozolomide
Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
|
Drug: temozolomide Genetic: protein expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunoenzyme technique |
Detailed Description:
OBJECTIVES:
Primary
- Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide.
Secondary
- Determine the overall survival of patients treated with this drug.
- Determine the radiographic response rate in patients treated with this drug.
- Determine the toxicity of this drug in theses patients.
- Determine the event-free survival of patients treated with this drug.
- Determine time to treatment failure.
Tertiary
- Evaluate surrogate markers for neo-angiogenesis to assess whether this mechanism plays a role in response in patients treated with this drug. (Samples are no longer being collected and tested as of 1/12/09)
OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Pathologically diagnosed glioblastoma multiforme or other malignant glioma
- Recurrent disease
- Must have received prior temozolomide
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- SGOT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 2 times ULN
- Bilirubin ≤ 2 times ULN
- No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin
- No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment
- No medical condition that precludes swallowing pills
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498927
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
Schering-Plough
Investigators
| Principal Investigator: | Antonio Omuro, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Thomas Kaley, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided by Memorial Sloan-Kettering Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00498927 History of Changes |
| Other Study ID Numbers: | 07-064, P30CA008748, MSKCC-07064, SPRI-PO5096 |
| Study First Received: | July 10, 2007 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
recurrent adult brain tumor adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult anaplastic astrocytoma adult diffuse astrocytoma adult pilocytic astrocytoma adult subependymal giant cell astrocytoma adult anaplastic ependymoma |
adult ependymoma adult myxopapillary ependymoma adult subependymoma adult anaplastic oligodendroglioma adult oligodendroglioma adult brain stem glioma adult mixed glioma adult pineal gland astrocytoma |
Additional relevant MeSH terms:
|
Glioblastoma Glioma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013