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Valstar (Valrubicin) - Summary



Valrubicin (N-trifluoroacetyladriamycin-14-valerate), a semisynthetic analog of the anthra-cycline doxorubicin, is a cytotoxic agent.

VALSTAR is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

See all Valstar indications & dosage >>


Media Articles Related to Valstar (Valrubicin)

Another Study Ties Pioglitazone to Bladder Cancer Risk (CME/CE)
Source: MedPage Today Endocrinology [2017.08.10]
(MedPage Today) -- Risk emerged within first 2 years; attenuated after discontinuing

Simple test predicts return of bladder cancer
Source: Urology / Nephrology News From Medical News Today [2017.07.10]
Scientists have devised a simple test for an earlier and more accurate warning of returning bladder cancer than existing methods, according to research published in the British Journal of Cancer.

'Couch Potatoes' May Face Higher Risk of Kidney, Bladder Cancers
Source: MedicineNet Bladder Cancer Specialty [2017.06.16]
Title: 'Couch Potatoes' May Face Higher Risk of Kidney, Bladder Cancers
Category: Health News
Created: 6/15/2017 12:00:00 AM
Last Editorial Review: 6/16/2017 12:00:00 AM

Studies: Concerns for bladder cancer risk of e-cigarette smokers and traditional smoking
Source: Smoking / Quit Smoking News From Medical News Today [2017.05.17]
Data being presented at the 112th Annual Scientific Meeting of the American Urological Association (AUA) shows harmful links between the use of e-cigarettes and bladder cancer risk, and associates...

E-Cigarettes Linked to Bladder Cancer Risk
Source: MedicineNet Bladder Cancer Specialty [2017.05.16]
Title: E-Cigarettes Linked to Bladder Cancer Risk
Category: Health News
Created: 5/15/2017 12:00:00 AM
Last Editorial Review: 5/16/2017 12:00:00 AM

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Published Studies Related to Valstar (Valrubicin)

Factors affecting valrubicin response in patients with bacillus Calmette-Guerin-refractory bladder carcinoma in situ. [2011.05]
OBJECTIVE: Patients with bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the bladder are candidates for intravesical (IVe) valrubicin. This post-hoc analysis of data from the pivotal phase 3, prospective, open-label study of valrubicin evaluated the effects of patient characteristics and past treatments on the response to valrubicin... CONCLUSIONS: In these patients with BCG-refractory CIS, complete responders to valrubicin did not differ significantly from partial or nonresponders in the number of prior courses or instillations. The results suggest that therapy with valrubicin may be considered in appropriate candidates who have not responded to prior therapies. Cystectomy should be reconsidered when valrubicin treatment fails.

Topical application of valrubicin has a beneficial effect on developing skin tumors. [2010.08]
Valrubicin is a second generation anthracycline characterized by an excellent safety profile presenting no skin toxicity or necrosis upon contact...

Valrubicin in a topical formulation treats psoriasis in a xenograft transplantation model. [2010.02]
Valrubicin is a cytostatic drug currently approved by the American Federal Drug Administration as a trademarked Valstar sterile solution for the treatment of bladder cancer. Valrubicin has shown an excellent therapeutic potential with minimal toxicity.

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Clinical Trials Related to Valstar (Valrubicin)

Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder [Terminated]
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of the bladder. The randomization will be 1: 1 and subjects will be stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).

Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG) [Completed]
This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.

Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma [Active, not recruiting]
The purpose of this study is to learn more about how well the drug valrubicin (VALSTARŪ) works to help treat the patient's cancer when administered through a nephrostomy tube inserted through their back into their kidney. The study is also being done to determine how safe and easy it is to tolerate valrubicin at specific dose levels, as well as the way in which the drug is eliminated from the human body (Pharmacokinetics or PK).

Retrospective Chart Review of Valstar [Completed]
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.

Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer [Active, not recruiting]
RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.

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Page last updated: 2017-08-10

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