Study of Pralatrexate to Treat Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00998946
First received: October 19, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient 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).


Condition Intervention Phase
Lymphoma, B-Cell
Drug: Pralatrexate Injection
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care by no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response (DOR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care by no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care by no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended. ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: September 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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).

    Initial dose: 30 mg/m2

    Dose reductions: to 20 mg/m2 weekly per protocol defined criteria.

    Administered on days 1, 8 and 15 of a 4-week (weekly for 3 weeks with one week of rest) until criteria for discontinuation per the protocol are met.

    Other Names:
    • FOLOTYN
    • PDX
    • Pralatrexate
    • (RS)-10-propargyl-10-deazaaminopterin
    Dietary Supplement: Vitamin B12

    1 mg intramuscular injection

    Administered within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate.

    Other Name: Cyanocobalamin
    Dietary Supplement: Folic Acid

    1 mg orally

    Administered daily for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days after last dose of pralatrexate.

    Other Names:
    • Vitamin B9
    • Folate
    • Folacin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of B-cell Non-Hodgkin's Lymphoma, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification
  • Measurable disease
  • 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 patients 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 patient must be disease-free for ≥ 5 years. Patients 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. Patients who received prophylactic CNS treatment are eligible.
  • Patients who have undergone an allogeneic SCT
  • Patients who have relapsed < 100 days from the time of an autologous SCT
  • Patients 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 patient 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 patient 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998946

Locations
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
United States, Idaho
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
Owsley Brown Frazier Cancer Center
Louisville, Kentucky, United States, 40245
United States, Louisiana
Overton Brooks VA Medical Center
Shreveport, Louisiana, United States, 71101
United States, Montana
Frontier Cancer Center and Blood Institute
Billings, Montana, United States, 59102
United States, New York
New York University Hospital
New York, New York, United States, 10016
United States, Oregon
Providence Cancer Center
Portland, Oregon, United States, 97225
United States, Tennessee
The West Clinic (ACORN)
Memphis, Tennessee, United States, 38120
United States, Wisconsin
Gundersen Lutheran
LaCrosse, Wisconsin, United States, 54601
University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53705-2275
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Pankaj Sharma, MD Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00998946     History of Changes
Other Study ID Numbers: PDX-015
Study First Received: October 19, 2009
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:
Relapsed
Refractory
Non-Hodgkin's

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Vitamins
10-deazaaminopterin
Aminopterin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014