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Hydroxyurea (Hydroxyurea) - Summary

 
 



HYDROXYUREA SUMMARY

HYDROXYUREA CAPSULES, USP

Hydroxyurea, an antineoplastic agent, available for oral use as capsules. Each capsule, for oral administration contains 500 mg hydroxyurea.

Hydroxyurea is indicated for the following:

Significant tumor response to hydroxyurea capsules, USP has been demonstrated in melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary.

Hydroxyurea used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip.


See all Hydroxyurea indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Hydroxyurea

New guideline created for managing sickle cell disease
Source: Blood / Hematology News From Medical News Today [2014.09.09]
An expert panel has created a new evidence-based guideline for managing sickle cell disease (SCD), with a strong recommendation for the use of the drug hydroxyurea and transfusion therapy for many...

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Published Studies Related to Hydroxyurea

Impact of hydroxyurea on clinical events in the BABY HUG trial. [2012]
The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups...

Effect of hydroxyurea treatment on renal function parameters: results from the multi-center placebo-controlled BABY HUG clinical trial for infants with sickle cell anemia. [2012]
CONCLUSION: Treatment with hydroxyurea for 24 months did not influence GFR in

Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: results from the BABY-HUG Phase III Clinical Trial. [2012]
CONCLUSIONS: These data provide additional support to the safety profile of

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH): a phase III randomized clinical trial for treatment of children with sickle cell anemia, stroke, and iron overload. [2011.12.01]
BACKGROUND: Stroke occurs in 5-10% of children with sickle cell anemia (SCA) and has a high (>50%) risk of recurrence without therapy. Chronic monthly erythrocyte transfusions effectively prevent recurrent stroke, but their long-term use is limited by serious side effects, including iron overload. An alternative to transfusion for secondary stroke prevention in SCA is needed, especially one that also improves the management of iron overload... CONCLUSION: Investigation of alternative treatments in SWiTCH could lead to changes in the management of cerebrovascular disease for selected patients with SCA, stroke, and iron overload. Copyright (c) 2011 Wiley-Liss, Inc.

Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: Results from the BABY-HUG phase III clinical trial. [2011.10.19]
CONCLUSIONS: These data provide additional support to the safety profile of hydroxyurea for young patients with SCA, and suggest that genotoxicity in this patient population is low. Pediatr Blood Cancer (c) 2011 Wiley Periodicals, Inc. Copyright (c) 2011 Wiley Periodicals, Inc.

more studies >>

Clinical Trials Related to Hydroxyurea

Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma [Completed]
This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma.

Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent MG [Recruiting]
Primary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of Zactima among MG pts on & not on EIAEDs when combo w imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on & not on EIAEDs when combo w Zactima & hydroxyurea Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among RMG pts including radiographic response rate, 6-month progression free survival rate & median PFS

Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera [Recruiting]
This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Recruited patients will be randomly assigned to one of the following treatment groups:

- group A: 50 mg o. d. of oral GIVINOSTAT (ITF2357) in combination with the maximum

tolerated dose of hydroxyurea monotherapy already in use before admission to the study;

- group B: 50 mg b. i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum

tolerated dose of hydroxyurea monotherapy already in use before admission to the study.

The two groups will be balanced for number and for Centre in order to provide valuable information on both treatment regimens.

In both groups assigned doses shall remain stable until week 12, which is when the primary endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.

After the primary endpoint assessment at week 12, one of the following treatment schedules will be chosen case by case on the basis of the achieved clinical response and continued for up to 12 further weeks:

- Partial or Complete Response at week 12:

- group A: continue 50 mg o. d.;

- group B: continue 50 mg b. i.d.;

- No Response at week 12:

- group A: increase to 50 mg b. i.d.;

- group B: increase to 50 mg t. i.d.. At any time during study course, if toxicity is

observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then restarted at a reduced dose level. The drug will be definitively withdrawn in case of reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last up to a maximum of 24 cumulative weeks of drug administration.

The study will recruit subjects of both genders with an established diagnosis of JAK2V617F positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM) [Active, not recruiting]
The objective of this study is to assess the efficacy and safety of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme.

Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM) [Active, not recruiting]
Investigational study to assess the overall response (OR) rate (CR + PR) of Imatinib mesylate and Hydroxyurea (Hydroxycarbamide) combination therapy on patients with recurrent glioblastoma multiforme (brain tumors). This study will also evaluate duration of tumor response (as per MacDonald criteria), clinical benefit, progression free survival rate at 6 and 12 month for the combined treatment and the survival rate at 12 and 24 months.

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Reports of Suspected Hydroxyurea Side Effects

Neoplasm Malignant (29)Death (15)Pneumonia (12)Skin Ulcer (8)Acute Myeloid Leukaemia (8)Respiratory Failure (8)Cardiac Failure (8)Maternal Exposure During Pregnancy (7)Platelet Count Increased (6)Drug Withdrawal Syndrome Neonatal (6)more >>


Page last updated: 2014-09-09

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