Cord CompressionPhase 2NCT03655080
Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
A Phase 2 study testing Radiation therapy and nab-Paclitaxel in people with Cord Compression, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cord Compression
- What is being tested?
- Radiation therapy and nab-Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 15 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Cord Compression
- Being tested
- Radiation therapy, nab-Paclitaxel
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Using the View Ray System
nab-PaclitaxelDrug
Also called Abraxane, Albumin-bound paclitaxel
- Dose 15 mg/m^2
- Should be administered by IV over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| nab-Paclitaxel and Radiation Therapy | Experimental | * 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 Receives: Radiation: Radiation therapy; Drug: nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start9 Jan 2019
- Primary completion22 Feb 2021
- Study completion15 Jun 2021
Why it stopped: Pharmaceutical company decided to close study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cord CompressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Hiram A Gay, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655080
- Sponsor's protocol ID
- 201809175
- Status last verified
- Jan 2025
- First submitted
- 29 Aug 2018
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach of Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
- ClinicalTrials.gov ID
- NCT03655080
- Acronym / sponsor ID
- 201809175
- Conditions
- Cord Compression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pharmaceutical company decided to close study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 18 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-Paclitaxel and Radiation Therapy | Experimental | Radiation: Radiation therapy, Drug: nab-Paclitaxel* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyUsing the View Ray System | Radiation | nab-Paclitaxel and Radiation Therapy |
| nab-PaclitaxelAlso: Abraxane, Albumin-bound paclitaxel* Dose 15 mg/m^2 * Should be administered by IV over 30 minutes | Drug | nab-Paclitaxel and Radiation Therapy |
Primary outcome
Ambulatory Status
Time frame: 1 month
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
10 secondary outcomes
Ambulatory Status
Time frame: 3 months
Ambulatory Status
Time frame: 6 months
Ambulatory Status
Time frame: 9 months
Ambulatory Status
Time frame: 12 months
Strength of Lower Extremities
Time frame: 1 month
Pain in the Irradiated Area" Measured on a Scale
Time frame: 1 month
Pain in the Irradiated Area Measured on a Scale
Time frame: 3 months
Pain in the Irradiated Area Measured on a Scale
Time frame: 6 months
Pain in the Irradiated Area Measured on a Scale
Time frame: 9 months
Pain in the Irradiated Area Measured on a Scale
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiram A Gay, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation therapy and nab-Paclitaxel in people with Cord Compression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Status (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.