A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
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| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10065 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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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.
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| Study Summary: |
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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)
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| Criteria: |
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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
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| NCT ID: |
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NCT00498927 |
| Primary Contact: |
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Principal Investigator
Antonio Omuro, MD
Memorial Sloan-Kettering Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10065
United States
Antonio Omuro, MD
Phone: 212-639-7523
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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