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A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent 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.

- 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)

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate at 6 months

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Antonio Omuro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-064

NCT ID:

NCT00498927

Start Date:

June 2007

Completion Date:

December 2014

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Glioblastoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021