Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    31
  • sponsor
    Washington University School of Medicine
Updated on 23 April 2021

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.

Details
Condition Spinal Cord Compression
Treatment radiation therapy, Nab-paclitaxel
Clinical Study IdentifierNCT03655080
SponsorWashington University School of Medicine
Last Modified on23 April 2021

Eligibility

Yes No Not Sure

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
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