Trial Outcomes & Findings for S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma (NCT NCT00003590)
NCT ID: NCT00003590
Last Updated: 2016-05-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Patients treated for 2 years or progression. If responding can continue at physician's discretion.
Results posted on
2016-05-20
Participant Flow
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.
All registered patients were to have eligibility assessed and sign informed consent prior to registration and receipt of protocol therapy.
Participant milestones
| Measure |
Hydroxyurea
Only eligible patients were included in the analyses.
Patients received 20 mg/kg/day taken orally.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
Eligible
|
28
|
|
Overall Study
Eligible and Began Protocol Therapy
|
28
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Hydroxyurea
Only eligible patients were included in the analyses.
Patients received 20 mg/kg/day taken orally.
|
|---|---|
|
Overall Study
Ineligible Patient
|
1
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma
Baseline characteristics by cohort
| Measure |
Hydroxyurea
n=28 Participants
Only eligible patients were included in the analyses.
Patients received 20 mg/kg/day taken orally.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Hydroxyurea
n=28 Participants
Patients received 20 mg/kg/day PO.
|
|---|---|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Complete Response (CR)
|
0 Participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Confirmed Partial Response (PR)
|
0 Participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Unconfirmed Complete Response (UCR)
|
0 Participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Unconfirmed Partial Response (UPR)
|
0 Participants
|
|
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
No Response
|
28 Participants
|
SECONDARY outcome
Timeframe: 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 monthsPopulation: 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.
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
Outcome measures
| Measure |
Hydroxyurea
n=28 Participants
Patients received 20 mg/kg/day PO.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Hydroxyurea
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydroxyurea
n=28 participants at risk
Patients received Hydroxyurea (20 mg/kg/day orally) up to 2 years in absence of progressive disease.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.7%
3/28 • 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.
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
10.7%
3/28 • 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.
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
21.4%
6/28 • 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.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
10.7%
3/28 • 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.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
12/28 • 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.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
10.7%
3/28 • 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.
|
|
General disorders
Edema
|
28.6%
8/28 • 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.
|
|
General disorders
Fatigue/malaise/lethargy
|
53.6%
15/28 • 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.
|
|
General disorders
Pain-other
|
17.9%
5/28 • 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.
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
7.1%
2/28 • 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.
|
|
Investigations
Alkaline phosphatase increase
|
10.7%
3/28 • 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.
|
|
Investigations
Bilirubin increase
|
10.7%
3/28 • 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.
|
|
Investigations
Leukopenia
|
67.9%
19/28 • 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.
|
|
Investigations
Lymphopenia
|
35.7%
10/28 • 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.
|
|
Investigations
Neutropenia/granulocytopenia
|
75.0%
21/28 • 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.
|
|
Investigations
Thrombocytopenia
|
50.0%
14/28 • 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.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
2/28 • 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.
|
|
Nervous system disorders
Dizziness/light headedness
|
25.0%
7/28 • 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.
|
|
Nervous system disorders
Headache
|
50.0%
14/28 • 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.
|
|
Nervous system disorders
Seizures
|
7.1%
2/28 • 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.
|
|
Nervous system disorders
Sensory neuropathy
|
7.1%
2/28 • 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.
|
|
Nervous system disorders
Weakness (motor neuropathy)
|
10.7%
3/28 • 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.
|
|
Psychiatric disorders
Depression
|
10.7%
3/28 • 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.
|
|
Renal and urinary disorders
Incontinence
|
7.1%
2/28 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.7%
3/28 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
2/28 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
2/28 • 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.
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: (206)667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place