Clinical trial NCT00998946: Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Official title: A Phase 2, Single-arm, Open-label, Multi-center Study of Pralatrexate in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Keywords: Relapsed
Refractory
Non-Hodgkin's
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).


Eligibility criteria: Inclusion Criteria:

* Histologically/cytologically confirmed, measurable (lesion or node =2 cm by CT \[at least 1 cm if by spiral CT\]) B-cell Non-Hodgkin's Lymphoma, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification
* Progressive or persistent disease after ≥ 1 prior treatment(s)
* Recovered from toxic effects of prior treatment
* At least 4 weeks since most recent cytotoxic therapy
* Easter Cooperative Oncology Group (ECOG) performance status ≤ 2
* Adequate blood, liver, and kidney functions as defined by laboratory levels
* 1.0 mg/day orally of folic acid for at least 7 days prior \& 1 mg intramuscular of vitamin B12 within 10 weeks of the planned start of pralatrexate
* Females of childbearing potential must agree to use medically acceptable birth control from start of pralatrexate until at least 30 days after the last administration of pralatrexate and must have a negative serum pregnancy test within 14 days prior to the first day of study treatment
* Males who are not surgically sterile must agree to use medically acceptable birth control from start of pralatrexate until at least 90 days after the last administration of pralatrexate
* Available for repeat dosing and follow-up
* Able to give written informed consent

Exclusion Criteria:

* Relapsed participants with diffuse large B-cell lymphoma (DLBCL) who are candidates for high-dose therapy and autologous stem cell transplantation (SCT) and for whom high-dose therapy and autologous SCT is a standard curative option
* Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancies other than those exceptions listed above, the participant must be disease-free for ≥ 5 years. Participants with other prior malignancies \< 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease
* Congestive heart failure Class III/IV according to the New York Heart Association Functional Classification
* Uncontrolled hypertension
* Known human immunodeficiency virus (HIV)-positive diagnosis
* Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Participants who received prophylactic CNS treatment are eligible.
* Participants who have undergone an allogeneic SCT
* Participants who have relapsed \< 100 days from the time of an autologous SCT
* Participants with disease refractory to peripheral blood SCT or who have relapsed \< 100 days from the time of transplant
* Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment.
* Major surgery within 14 days of enrollment
* Receipt of any conventional chemotherapy or radiation therapy (encompassing a substantial \[\> 10%\] amount of bone marrow) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the course of the study
* Receipt of systemic corticosteroids within 1 week of study treatment, unless participant has been taking a continuous dose of no more than 10 mg/day of prednisone or its equivalent for at least 1 month
* Use of any investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the course of the study
* Previous exposure to pralatrexate
* Females who are pregnant or breastfeeding

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to 24 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 24 months
measure: Overall Survival (OS)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Louisville
country: United States
facility: Owsley Brown Frazier Cancer Center
state: Kentucky
city: Shreveport
country: United States
facility: Overton Brooks VA Medical Center
state: Louisiana
city: Billings
country: United States
facility: Frontier Cancer Center and Blood Institute
state: Montana
city: New York
country: United States
facility: New York University Hospital
state: New York
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
city: Memphis
country: United States
facility: The West Clinic (ACORN)
state: Tennessee
city: La Crosse
country: United States
facility: Gundersen Lutheran
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
References: