Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
|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.
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.
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: Cyanocobalamin
Dietary 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.
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|