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

Primary Purpose

Cord Compression

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation therapy
nab-Paclitaxel
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cord Compression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nab-Paclitaxel and Radiation Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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)
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)
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)
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)
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)
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)

Full Information

First Posted
August 29, 2018
Last Updated
October 15, 2021
Sponsor
Washington University School of Medicine
Collaborators
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT03655080
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Pharmaceutical company decided to close study
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Celgene

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cord Compression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nab-Paclitaxel and Radiation Therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Using the View Ray System
Intervention Type
Drug
Intervention Name(s)
nab-Paclitaxel
Other Intervention Name(s)
Abraxane, Albumin-bound paclitaxel
Intervention Description
Dose 15 mg/m^2 Should be administered by IV over 30 minutes
Primary Outcome Measure Information:
Title
Ambulatory Status
Description
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Ambulatory Status
Description
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time Frame
3 months
Title
Ambulatory Status
Description
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time Frame
6 months
Title
Ambulatory Status
Description
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time Frame
9 months
Title
Ambulatory Status
Description
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Time Frame
12 months
Title
Strength of Lower Extremities
Description
-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)
Time Frame
1 month
Title
Pain in the Irradiated Area" Measured on a Scale
Description
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time Frame
1 month
Title
Pain in the Irradiated Area Measured on a Scale
Description
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time Frame
3 months
Title
Pain in the Irradiated Area Measured on a Scale
Description
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time Frame
6 months
Title
Pain in the Irradiated Area Measured on a Scale
Description
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time Frame
9 months
Title
Pain in the Irradiated Area Measured on a Scale
Description
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiram A Gay, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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