Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | June 2007 |
| End Date: | December 2013 |
A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
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.
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.
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.
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)
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.
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)
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
We found this trial at
1
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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