Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Spectrum Pharmaceuticals, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: Pralatrexate Injection
  • Drug: Gemcitabine Hydrochloride
  • Dietary Supplement: Vitamin B12
  • Dietary Supplement: Folic Acid

Phase:

Phase 1/Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting