Trial Outcomes & Findings for Combination of Hydroxyurea and Verapamil for Refractory Meningiomas (NCT NCT00706810)

NCT ID: NCT00706810

Last Updated: 2017-04-13

Results Overview

Adverse Events assessed in accordance with CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: two years
• Results posted on: 2017-04-13

Participant Flow

Participant milestones

Measure	All Participants Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease. Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination of Hydroxyurea and Verapamil for Refractory Meningiomas

Baseline characteristics by cohort

Measure	All Groups n=7 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants
Sex/Gender, Customized Female	6 participants n=5 Participants
Sex/Gender, Customized Male	1 participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: two years

Adverse Events assessed in accordance with CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.

Outcome measures

Measure	All Groups n=7 Participants
Number of Participants Experiencing Serious Adverse Events Including But Not Limited to Hospitalizations, Deaths Related to Treatment, or Other Incapacitating Conditions.	0 participants

SECONDARY outcome

Timeframe: 31 months

Response and progression will be evaluated in this study using measurements from the MRI/CT scans. Measurements will be made of the image slice with the largest cross sectional area. Two orthogonal measures will be made to determine maximal AP and lateral dimensions. Progression of disease will be defined as a greater than 25% increase of largest cross sectional area by two orthogonal measurements, taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Measure	All Groups n=7 Participants
Median Progression-free Survival Rates of the Treatment Population.	8.0 months Interval 5.0 to 31.0

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=7 participants at risk Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease. Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day.
Gastrointestinal disorders abdominal pain	14.3% 1/7
Blood and lymphatic system disorders anemia	71.4% 5/7
Musculoskeletal and connective tissue disorders back pain	14.3% 1/7
Gastrointestinal disorders constipation	42.9% 3/7
Eye disorders decreased eye acuity	14.3% 1/7
Nervous system disorders dizziness	28.6% 2/7
Infections and infestations ear infection	14.3% 1/7
Vascular disorders edema	14.3% 1/7
General disorders fatigue	28.6% 2/7
Nervous system disorders headache	14.3% 1/7
Cardiac disorders heart palpatations	14.3% 1/7
Metabolism and nutrition disorders hypocalcemia	14.3% 1/7
Metabolism and nutrition disorders hyponatremia	14.3% 1/7
Blood and lymphatic system disorders leukopenia	85.7% 6/7
Nervous system disorders lightheaded	14.3% 1/7
Blood and lymphatic system disorders neutropenia	85.7% 6/7
Gastrointestinal disorders parotitis	14.3% 1/7
Eye disorders proptosis	14.3% 1/7
Infections and infestations sinus infection	14.3% 1/7
Infections and infestations strep throat	14.3% 1/7
Nervous system disorders syncope	14.3% 1/7
Blood and lymphatic system disorders thrombocytopenia	85.7% 6/7
Infections and infestations urinary tract infection	28.6% 2/7
Nervous system disorders vasovagal	14.3% 1/7
Investigations weight gain	14.3% 1/7
Musculoskeletal and connective tissue disorders wrist sprain	14.3% 1/7

Additional Information

Dr. Randy Jensen

Huntsman Cancer Institute

Phone: 801-581-6908

Email: randy.jensen@hci.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place