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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cord Compression
• Intervention / Treatment: Radiation: Radiation therapy; Drug: nab-Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: nab-Paclitaxel and Radiation Therapy; 10 fractions of 3Gy radiation therapy will be delivered.; A total of 4 chemoradiation blocks should be delivered ideally in consecutive days; On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel); On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day; There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks

Radiation: Radiation therapy; Using the View Ray System; Drug: nab-Paclitaxel; Dose 15 mg/m^2; Should be administered by IV over 30 minutes; Other Names: Abraxane; Albumin-bound paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory Status	-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory Status	-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.	3 months
Ambulatory Status	-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.	6 months
Ambulatory Status	-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.	9 months
Ambulatory Status	-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.	12 months
Strength of Lower Extremities	-Strength assessment is categorized as follows: 0/5=no contraction (worst); 1/5=muscle flicker, but no movement; 2/5=movement possible, but not against gravity (test the joint in its horizontal plane); 3/5=movement possible against gravity, but not against resistance by the examiner; 4/5=movement possible against some resistance by the examiner; 5/5=normal strength (best)	1 month
Pain in the Irradiated Area" Measured on a Scale	-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)	1 month
Pain in the Irradiated Area Measured on a Scale	-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)	3 months
Pain in the Irradiated Area Measured on a Scale	-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)	6 months
Pain in the Irradiated Area Measured on a Scale	-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)	9 months
Pain in the Irradiated Area Measured on a Scale	-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)	12 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Celgene

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2019
• Primary Completion (ACTUAL): February 22, 2021
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (ACTUAL): August 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries; Spinal Cord Compression; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 201809175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes