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A phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard

Award Number: R01FD003017
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/20/2006
PERIOD OF PERFORMANCE END DATE: 09/24/2009

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A phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard - DESCRIPTION (provided by applicant): This application is for a competitive continuation which currently provides two-years funding for a Phase 2, pivotal trial testing the safety and efficacy of topical NM formulations in patients with MF. MF is the most common type of cutaneous T-cell lymphoma. NM is an alkylating agent, used in the systemic treatment of lymphomas. NM compounded into petrolatum or AP may be a safe and effective topical treatment of MF. A PG-containing ointment formulation has been developed as an alternative to the heavy AP vehicle which can be difficult to apply to the skin and can compromise patient compliance. A multi-center, randomized, observer-blind trial has been initiated to test the safety and efficacy of a manufactured 0.02% NM PG ointment versus a compounded 0.02% NM AP ointment in 118 patients. It is anticipated that accrual will be completed by year two but assessment will continue into and be completed by year three. Established patients with Stage Ia, Ib or IIa MF, with no prior topical NM or carmustine (BCNU) therapy, are eligible. Primary and secondary efficacy endpoints are the Composite Assessment of Index Lesion Severity and Severity Weighted Assessment Tool, respectively. Patients apply study ointment to affected skin areas (lesions) or total skin surface (depending on stage) once daily for up to 12 months. The frequency of application can be adjusted for toxicity. Tumor response and toxicity are assessed every 4 weeks from months 1 to 6 and every 8 weeks from months 7 to12. Additional toxicity data (squamous cell carcinoma) will be captured in an extended 12-month follow-up.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2008	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	002	3	3/15/2016	COMPETING CONTINUATION	$0
2016	2008	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	001	3	2/19/2016	COMPETING CONTINUATION	$0
2016	2007	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	000	2	12/28/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $0 )
2014	2009	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	000	4	12/31/2013	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2010 ( Subtotal = $95,747 )
2010	2010	FOX CHASE CANCER CENTER	333 Cottman Ave	Philadelphia	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	001	4	8/31/2010	SUPPLEMENT FOR EXPANSION	$95,747
2010	2009	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	000	4	7/23/2010	COMPETING CONTINUATION	$0
														Subtotal = $95,747

Issue Date FY: 2009 ( Subtotal = $304,253 )
2009	2009	FOX CHASE CANCER CENTER	333 Cottman Ave	Philadelphia	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	002	4	9/22/2009	COMPETING CONTINUATION	$304,253
2009	2008	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	001	3	9/22/2009	COMPETING CONTINUATION	$0
2009	2008	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	000	3	3/6/2009	COMPETING CONTINUATION	$0
														Subtotal = $304,253

Issue Date FY: 2008 ( Subtotal = $421,843 )
2008	2008	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	000	3	3/7/2008	COMPETING CONTINUATION	$421,843
														Subtotal = $421,843

Issue Date FY: 2007 ( Subtotal = $349,999 )
2007	2007	FOX CHASE CANCER CENTER	7701 BURHOLME AVE	PHILADELPHIA	PA	19111	PHILADELPHIA	USA	Food and Drug Administration Research	000	2	8/31/2007	NON-COMPETING CONTINUATION	$349,999
														Subtotal = $349,999

Grand Total All Awards = $1,171,842

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A phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard

Award Number: R01FD003017

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/20/2006

PERIOD OF PERFORMANCE END DATE: 09/24/2009

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