Cord Compression
Conditions
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.
Interventions
RADIATIONRadiation therapy
Using the View Ray System
DRUGnab-Paclitaxel
* Dose 15 mg/m\^2 * Should be administered by IV over 30 minutes
Sponsors
Celgene
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory Status | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory Status | 3 months | -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 | 1 month | -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 | 1 month | -Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Age, Continuous | 47.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
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.
Time frame: 1 month
Population: One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nab-Paclitaxel and Radiation Therapy | Ambulatory Status | Paraplegic | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Ambulatory Status | Not ambulatory | 1 Participants |
| Nab-Paclitaxel and Radiation Therapy | Ambulatory Status | Ambulatory with aid | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Ambulatory Status | Ambulatory without aid | 0 Participants |
Secondary
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.
Time frame: 12 months
Population: Both participants expired prior to the 12 month follow-up.
Secondary
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.
Time frame: 3 months
Population: One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant. One participant was not evaluable for this outcome measure because the participant died prior to the 3 month follow-up.
Secondary
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.
Time frame: 6 months
Population: Both participants expired prior to the 6 month follow-up.
Secondary
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.
Time frame: 9 months
Population: Both participants expired prior to the 9 month follow-up.
Secondary
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)
Time frame: 12 months
Population: Both participants expired prior to the 12 month follow-up.
Secondary
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)
Time frame: 1 month
Population: One participant was not evaluable for this outcome measure because the pain scale was not completed for the participant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 0 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 1 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 2 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 3 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 4 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 5 | 1 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 6 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 7 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 8 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 9 | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Pain in the Irradiated Area Measured on a Scale | 10 | 0 Participants |
Secondary
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)
Time frame: 3 months
Population: One participant was not evaluable for this outcome measure because the pain status was not completed for the participant. One participant was not evaluable for this outcome measure because the participant died prior to the 3 month follow-up.
Secondary
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)
Time frame: 6 months
Population: Both participants expired prior to the 6 month follow-up.
Secondary
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)
Time frame: 9 months
Population: Both participants expired prior to the 9 month follow-up.
Secondary
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)
Time frame: 1 month
Population: One participant was not evaluable for this outcome measure because the strength of lower extremities was not completed for the participant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nab-Paclitaxel and Radiation Therapy | Strength of Lower Extremities | 4=movement possible against some resistance by the examiner | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Strength of Lower Extremities | 5=normal strength | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Strength of Lower Extremities | 0=no contraction | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Strength of Lower Extremities | 1=muscle flicker, but no movement | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Strength of Lower Extremities | 2=movement possible, but not against gravity (test the joint in its horizontal plane) | 0 Participants |
| Nab-Paclitaxel and Radiation Therapy | Strength of Lower Extremities | 3=movement possible against gravity, but not against resistance by the examiner | 1 Participants |