Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Condition: Cord Compression
MeSH terms: Spinal Cord Compression
Intervention: Radiation therapy; nab-Paclitaxel
Intervention description: Using the View Ray System; Dose 15 mg/m^2
Should be administered by IV over 30 minutes
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to look at a combination treatment of radiation therapy
      and a drug called Abraxane to treat epidural spinal cord compression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with ≤ 37 points per the scoring system listed in the protocol

          -  Histologically or cytologically confirmed diagnosis of cancer not of CNS or spinal
             column origin.

          -  MRI or CT evidence of metastatic epidural spinal cord compression.

          -  Patients who have started 30 Gy in 10 fractions are not excluded as long as 4 doses of
             chemotherapy could potentially be given. This means the latest nab-paclitaxel can
             start is the morning of the third fraction of radiotherapy. Radiotherapy should
             ideally be delivered at least 6 hours after the nab-paclitaxel infusion started.

          -  At least 18 years of age.

          -  Normal bone marrow and organ function as defined below:

               -  Absolute neutrophil count ≥ 1,500 cells/mm3

               -  Platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving
                  platelet transfusions within 7 days prior to blood draw)

               -  Hemoglobin > 9.0 g/dL

               -  Total bilirubin ≤ 1.5 mg/dL

               -  AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN

               -  Alkaline phosphatase ≤ 2.5 x IULN (unless bone metastasis is present (< 5 x IULN)
                  in the absence of liver metastasis)

               -  Creatinine ≤ 1.5 mg/dL

          -  Women of childbearing potential (defined as a sexually mature woman who (1) has not
             undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally
             postmenopausal for at least 24 consecutive months) must:

               -  Either commit to true abstinence from heterosexual contact (which must be
                  reviewed on a monthly basis) or agree to use, and be able to comply with,
                  effective contraception without interruption, 28 days prior to starting treatment
                  with nab-paclitaxel and while on study; and

               -  Have a negative serum pregnancy test result at screening and agree to ongoing
                  pregnancy testing during the course of the study and after the end of study
                  therapy. This applies even if the subject practices true abstinence from
                  heterosexual contact.

          -  Male subjects must practice true abstinence or agree to use a condom during sexual
             contact with a pregnant female or a female of childbearing potential while
             participating in the study, during dose interruptions, and for 6 months following
             nab-paclitaxel discontinuation, even if he has undergone a successful vasectomy.

          -  Ability to understand and willingness to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable).

        Exclusion Criteria:

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
             arrhythmia.

          -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
             serum pregnancy test prior to study entry.

          -  Known HIV-positivity on combination antiretroviral therapy because of the potential
             for pharmacokinetic interactions with nab-paclitaxel. In addition, these patients are
             at increased risk of lethal infections when treated with marrow-suppressive therapy.
             Appropriate studies will be undertaken in patients receiving combination
             antiretroviral therapy when indicated.

          -  Previous spinal cord radiotherapy that would overlap with the proposed treatment
             field.

          -  Spinal instability or bony retropulsion causing the cord compression. That is,
             mechanical, not tumor, cord compression. In these cases surgery may be indicated.

          -  Patients eligible for surgical decompression like laminectomy.