Clinical trial NCT03655080: Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Official title: Novel Approach of Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cord Compression
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2018-08-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Ambulatory Status
timeFrame: 1 month
Secondary outcomes:
measure: Ambulatory Status
timeFrame: 3 months
measure: Ambulatory Status
timeFrame: 6 months
measure: Ambulatory Status
timeFrame: 9 months
measure: Ambulatory Status
timeFrame: 12 months
measure: Strength of Lower Extremities
timeFrame: 1 month
measure: Pain in the Irradiated Area" Measured on a Scale
timeFrame: 1 month
measure: Pain in the Irradiated Area Measured on a Scale
timeFrame: 3 months
measure: Pain in the Irradiated Area Measured on a Scale
timeFrame: 6 months
measure: Pain in the Irradiated Area Measured on a Scale
timeFrame: 9 months
measure: Pain in the Irradiated Area Measured on a Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hiram A Gay, M.D.
role: PRINCIPAL_INVESTIGATOR
References: