Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL.
Cutaneous T-cell Lymphoma
Primary Cutaneous Anaplastic Large Cell Lymphoma
Drug: Pralatrexate Injection
Drug: Bexarotene Capsules
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Dose Limiting Toxicity (DLT) Rate [ Time Frame: Assessed weekly through cycle 1 (weeks 1-4) ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: Yes ]
- 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). ] [ Designated as safety issue: Yes ]This was collected during the dose-finding stage of the study. PK sampling is not included in the cohort expansion.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|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).
|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|