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Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

Information source: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsed or Refractory Lymphoproliferative Malignancies; Hodgkin's Lymphoma; Peripheral T-cell Lymphoma; B-cell Lymphoma; Waldenstrom's Macroglobulinemia

Intervention: Pralatrexate Injection (Drug); Gemcitabine Hydrochloride (Drug); Vitamin B12 (Dietary Supplement); Folic Acid (Dietary Supplement)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Spectrum Pharmaceuticals, Inc

Official(s) and/or principal investigator(s):
Michael Saunders, MD, Study Director, Affiliation: Spectrum Pharmaceuticals, Inc

Summary

This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia. This study is being done to find doses of the combination of pralatrexate and gemcitabine with vitamin B12 and folic acid that can be safely given to patients with these types of lymphoma and explore the effectiveness of the treatment.

Clinical Details

Official title: A Phase 1/2a Open-label Study of Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Objective Responses Assessed by International Workshop Criteria (IWC)

Secondary outcome:

Duration of Response

Progression-free Survival (PFS) Time

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Phase 1: Histologically/cytologically confirmed lymphoproliferative malignancy.

Patients with Hodgkin lymphoma (HL) or non-HL are eligible, with exceptions per exclusion criteria.

- Phase 2a: Histologically/cytologically confirmed HL, peripheral T-cell lymphoma

(PTCL), or B-cell lymphoma including Waldenström's macroglobulinemia, with exceptions per exclusion criteria.

- Progression of disease (PD) after at least 1 prior treatment (any number of prior

therapies allowed). PD after last prior treatment and recovered from toxic effects of prior therapy. Patients treated with an FDA-approved monoclonal antibody therapy may be enrolled at any time after the therapy if they have PD.

- PTCL patients must have received single-agent pralatrexate as a prior therapy.

- Eastern Cooperative Oncology Group performance status ≤ 2.

- Adequate blood, liver and kidney function per laboratory tests.

- Has taken 1 mg daily oral folic acid for at least 7 days prior to planned start of

pralatrexate and received 1 mg vitamin B12 intramuscularly within 10 weeks of the planned start of pralatrexate.

- Females of childbearing potential must practice a medically acceptable contraceptive

regimen from first dose until at least 30 days after last dose of pralatrexate and have a negative serum pregnancy test within 14 days prior to the first day of study treatment. Postmenopausal (defined as greater than 12 months since last menses) and surgically sterilized females do not require this test.

- Males who are not surgically sterile must practice a medically acceptable

contraceptive regimen from first dose until at least 90 days after last dose of pralatrexate.

- Give written informed consent.

Exclusion Criteria:

- Phase 1

1. B-cell: lymphoplasmacytic lymphoma (± Waldenström's macroglobulinemia); plasma cell myeloma/plasmacytoma; hairy cell leukemia.

- Phase 2a

1. PTCL: precursor T/Natural Killer (NK) neoplasms, with the exception of blastic NK lymphoma; T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; mycosis fungoides (MF), except transformed MF; Sézary syndrome; primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis. 2. B-cell: plasma cell myeloma/plasmacytoma; hairy cell leukemia.

- Relapsed HL or diffuse large B-cell lymphoma patients who are candidates for high

dose therapy and autologous stem cell transplantation (SCT) and for whom it 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 malignancy, must be disease free for at least 5 years.

- Congestive heart failure Class III/IV.

- Uncontrolled hypertension.

- Human immunodeficiency virus (HIV)- positive diagnosis with CD4 less than 100 or

detectable viral load within past 3 months and receiving anti-retroviral therapy.

- Hepatitis B or C virus with detectable viral load or immunological evidence of

chronic active disease or receiving/requiring antiviral therapy.

- Central nervous system disease.

- Undergone an allogeneic SCT.

- Patients with disease refractory to peripheral blood SCT, or who have relapsed less

than 100 days since an autologous or peripheral blood SCT.

- Active uncontrolled infection, underlying medical condition including unstable heart

disease, or other serious illness impairing the ability to receive protocol treatment.

- Major surgery within 2 weeks of planned start of treatment.

- Receipt of any conventional chemotherapy or radiation therapy (encompassing greater

than 10% of bone marrow) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the study.

- Receipt of systemic corticosteroids within 7 days of study treatment, unless on a

continuous dose of no more than 10 mg/day of prednisone for at least 1 month.

- Use of investigational drugs, biologics, or devices within 4 weeks prior to study

treatment or planned use during the study.

- Received a monoclonal antibody within 3 months without evidence of PD.

- Previous exposure to pralatrexate and/or gemcitabine if discontinued due to

treatment-related toxicity.

Locations and Contacts

University of California at Los Angeles, Los Angeles, California 90095-7077, United States

Stanford University School of Medicine, Stanford, California 94305, United States

Rocky Mountain Cancer Center, Denver, Colorado 80218, United States

University of Chicago Hospital, Chicago, Illinois 60637, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115-6013, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10017, United States

New York University Hospital, New York, New York 10016, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

UT MD Anderson Cancer Center, Houston, Texas 77030, United States

Cancer Therapy & Research Center, San Antonio, Texas 78229-4427, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States

Additional Information

Starting date: May 2007
Last updated: May 8, 2013

Page last updated: August 23, 2015

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