Adult Meningioma
Conditions
Keywords
recurrent adult brain tumor, adult grade I meningioma
Brief summary
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.
Detailed description
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.
Interventions
DRUGhydroxyurea
20 mg/kg/day PO
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | 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 |
Countries
United States
Participant flow
Recruitment details
This study was activated on November 15, 1998 and closed to accrual on June 1, 2005. This was open to all SWOG institutions with IRB approval. Eastern Cooperative Oncology Group (ECOG) joined this trial on May 14, 2004.
Pre-assignment details
All registered patients were to have eligibility assessed and sign informed consent prior to registration and receipt of protocol therapy.
Participants by arm
| Arm | Count |
|---|---|
| Hydroxyurea Only eligible patients were included in the analyses.
Patients received 20 mg/kg/day taken orally. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 1 |
| Overall Study | Ineligible Patient | 1 |
| Overall Study | Lack of Efficacy | 11 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Hydroxyurea |
|---|---|
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
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).
Time frame: Patients treated for 2 years or progression. If responding can continue at physician's discretion.
Population: All eligible patients who started treatment were included in assessing response estimates.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydroxyurea | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Complete Response (CR) | 0 Participants |
| Hydroxyurea | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Confirmed Partial Response (PR) | 0 Participants |
| Hydroxyurea | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Unconfirmed Complete Response (UCR) | 0 Participants |
| Hydroxyurea | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | Unconfirmed Partial Response (UPR) | 0 Participants |
| Hydroxyurea | Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) | No Response | 28 Participants |
Secondary
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug
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
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
Population: Eligible patients who had received any hydroxyurea were included in the adverse event summaries. Any CTC 2.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Anemia | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Confusion | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Dyspnea | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Fatigue/malaise/lethargy | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Headache | 2 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Hypoxia | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Inner ear-hearing loss | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Leukopenia | 3 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 2 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Neutropenia/granulocytopenia | 10 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Respiratory infect w/o neutrop | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Respiratory infection, unk ANC | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Syncope | 1 Participants with a given type of AE |
| Hydroxyurea | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug | Thrombocytopenia | 1 Participants with a given type of AE |