Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

January 31, 2012

Study Completion Date

February 29, 2012

Conditions
Cutaneous T-cell Lymphoma
Interventions
DIETARY_SUPPLEMENT

Vitamin B12

"1 mg intramuscular injection~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.~Administered every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate."

DIETARY_SUPPLEMENT

Folic Acid

"1 mg orally~Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels.~Administered daily throughout the study and for at least 30 days after last dose of pralatrexate."

DRUG

Pralatrexate

Intravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or

Trial Locations (10)

10017

Memorial Sloan-Kettering Cancer Center, New York

10032

Columbia University Medical Center, New York

30322

Emory University, Atlanta

63110

Washington University School of Medicine, St Louis

91010

City of Hope National Medical Center, Duarte

94063

Stanford University School of Medicine, Redwood City

98109

Fred Hutchinson Cancer Center, Seattle

06519

Yale University School of Medicine, New Haven

02215

Dana-Farber Cancer Institute, Boston

77080-4009

University of Texas MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
lead

Acrotech Biopharma Inc.

INDUSTRY

NCT00554827 - Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma | Biotech Hunter | Biotech Hunter