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NCT Number: NCT00003590

S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.

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Key information

Conditions

Adult Meningioma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital, Fairbanks, Alaska, United States

Loading trial locations.

About this study

OBJECTIVES:

  • Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea.
  • Assess the quantitative and qualitative toxic effects of this drug in this patient population.

OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable primary, recurrent, or residual benign meningioma
  • Measurable disease by CT scan or MRI
  • Must have disease progression within the past 10 years OR progressive neurologic deficit within the past 6 months
  • Must have undergone prior radiotherapy with subsequent disease progression OR refused radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least lower limit of normal

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior cytotoxic chemotherapy for meningioma
  • Prior mifepristone allowed
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to CT scan or MRI
  • No concurrent antitumor hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Treatment and study plan

Hydroxyurea

Drug

20 mg/kg/day PO

Primary outcomes

  1. Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)

    Time frame: Patients treated for 2 years or progression. If responding can continue at physician's discretion.

    Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed).

Secondary outcomes

  1. Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug

    Time frame: Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months

    Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Study of Hydroxyurea for Unresectable Meningioma

Important dates

Study start
1998
Primary completion
2008
Study completion
2011
First posted
Jan 27, 2003
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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