Completed

Phase 2
Age: 18Years - 120Years
All Genders
ID00498927

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2016-02-29

47

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial