Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01134341|
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : July 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome Primary Cutaneous Anaplastic Large Cell Lymphoma||Drug: Pralatrexate Injection Drug: Bexarotene Capsules Dietary Supplement: Vitamin B12 Dietary Supplement: Folic Acid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
|Experimental: Pralatrexate & Bexarotene||
Drug: Pralatrexate Injection
Intravenous (IV) push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride).
10 or 15 mg/m2, depending on cohort assignment.
Dose reductions allowed for protocol-specified criteria.
Administered weekly for 3 weeks of 4-week cycle (weekly for 3 weeks with one week of rest) until criteria for discontinuation per the protocol are met.
Other Names:Drug: Bexarotene Capsules
150 or 300 mg orally, depending on cohort assignment. Provided as 75 mg capsules and taken with a meal.
Dose reductions allowed for protocol-specified criteria and implemented per the Targretin® package insert.
Administered daily until criteria for study treatment discontinuation per the protocol are met.
Other Names:Dietary Supplement: Vitamin B12
1 mg intramuscular injection
Administered within 10 weeks prior to start of study treatment, every 8-10 weeks throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene).
Other Name: CyanocobalaminDietary Supplement: Folic Acid
1-1.25 mg orally
Administered daily for at least 7 days prior to start of study treatment, throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene).
- Dose Limiting Toxicity (DLT) Rate [ Time Frame: Assessed weekly through cycle 1 (weeks 1-4) ]
- Overall Response Rate (ORR) [ Time Frame: Assessed after every 2 cycles (8 weeks) for the first 12 months, then every 4 cycles (16 weeks) until progression of disease. ]
- Number of Patients with Treatment-related Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Recorded at all study visits: weekly (every 7 +/- 2 days) while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal). ]
- Pharmacokinetic Parameters [ Time Frame: Sampling through 24 hours post end-injection of pralatrexate in cycle 1 dose 1 (week 1) and cycle 1 dose 3 (week 3). ]This was collected during the dose-finding stage of the study. PK sampling is not included in the cohort expansion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134341
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Ospedale Sant'Orsola - Policlinico Sant'Orsola|
|Bologna, Italy, 40138|
|Study Director:||Pankaj Sharma, MD||Spectrum Pharmaceuticals, Inc|