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Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma


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

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Trial Information

Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma


OBJECTIVES:

- Determine complete, partial, or stable response to hydroxyurea in patients with
recurrent and/or nonresectable meningioma.

- Determine response at 2 years to this regimen in these patients.

- Determine overall and disease free survival of these patients after this regimen.

- Determine quality of life of these patients.

- Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease
(I vs II or III).

Patients receive oral hydroxyurea daily for 2 years.

Quality of life is assessed before treatment, then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven progressive meningioma that is not curable by surgery

PATIENT CHARACTERISTICS:

Age:

- 16 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Over 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST and ALT no greater than 2 times ULN

- Alkaline phosphatase no greater than 2 times ULN

Renal:

- Creatinine no greater than 2 times ULN

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 6 months after study

- No other malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Concurrent corticosteroids allowed for control of intracranial pressure

Radiotherapy:

- Prior radiotherapy allowed

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- At least 1 year since prior experimental therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Didier Frappaz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Leon Berard

Authority:

United States: Federal Government

Study ID:

CDR0000068132

NCT ID:

NCT00006119

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult grade III meningioma
  • adult grade I meningioma
  • adult grade II meningioma
  • Meningioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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