Nervous System Diseases

Wounds and Injuries

All Conditions

Spinal Cord Compression

Spinal Cord Diseases

Central Nervous System Diseases

Spinal Cord Injuries

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

* 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 therapy

* Dose 15 mg/m\^2
* Should be administered by IV over 30 minutes

nab-Paclitaxel

Hiram A Gay, M.D.

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.

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

-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 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 is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)

Celgene

Washington University School of Medicine

Nab-Paclitaxel and Radiation Therapy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Hiram A. Gay, M.D.

Paraplegic

Not ambulatory

Ambulatory with aid

Ambulatory without aid

One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant.

Ambulatory Status

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.

Both participants expired prior to the 6 month follow-up.

Both participants expired prior to the 9 month follow-up.

Both participants expired prior to the 12 month follow-up.

0=no contraction

1=muscle flicker, but no movement

2=movement possible, but not against gravity (test the joint in its horizontal plane)

3=movement possible against gravity, but not against resistance by the examiner

4=movement possible against some resistance by the examiner

5=normal strength

One participant was not evaluable for this outcome measure because the strength of lower extremities was not completed for the participant.

Strength of Lower Extremities

One participant was not evaluable for this outcome measure because the pain scale was not completed for the participant.

Pain in the Irradiated Area" Measured on a Scale

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.

Pain in the Irradiated Area Measured on a Scale

Overall Study

Neoplasms

Symptoms and General Pathology

Musculoskeletal Diseases

Neoplasm Metastasis

Spinal Diseases

Spinal Cord Neoplasms

Spinal Neoplasms

Neoplastic Processes

Bone Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Bone Neoplasms

Central Nervous System Depressants

Anesthetics

Melphalan

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Subjects recruited to this study will receive intra-arterial injections of chemotherapy (melphalan) in the branches of the arteries feeding the metastatic spinal tumor. Subjects will receive general anesthesia or conscious sedation. A catheter will be guided using X-ray from the femoral artery at the top of the leg to the arteries of the spine. A dye will be injected through the catheter to show the arteries in greater detail. The chemotherapy is then injected into the tumor. We will inject the maximum systemic dose adjusted to white blood count and platelet count. Subjects will undergo three cycles of chemotherapy three to six weeks apart.

Patients will undergo a minimally invasive procedure called spinal angiography. This procedure will identify the arteries feeding the tumor causing cord compression and will determine whether chemotherapy can be safely infused.

The chemotherapy will be infused via a tiny soft plastic tube (called "microcatheter") at the tumor site over approximately 30 minutes.

The drug of choice is melphalan (trade name Alkeran) at a maximum dose of 16mg/m2, adjusted for white cell count, platelet count and renal function.

We will perform up to three intra-arterial chemotherapy treatments in 3-6 week intervals, based on the results of complete blood counts.

Melphalan (intra-arterial infusion)

Athos Patsalides

Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a clinical entity known as cord compression that manifests with progressive loss of motor function and sensation in the legs, as well as bladder and bowel incontinence.

The treatment of spinal metastases is mostly palliative with the goals of improving or maintaining neurologic function, achieving local tumor control, and spinal stability. Most patients with spinal metastatic disease are currently treated effectively with radiation therapy and/or surgery with good results. There are however certain limitations in the current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted SMD is in close proximity the spinal cord, delivery of high radiation doses is contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and 2) there is limit on the cumulative amount of radiation dose, which means that recurrent tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned, the main limitation is that some patients are not fit for surgery because of medical co-morbidities.

This phase I clinical research trial will test the hypothesis that a new minimally invasive treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients with SMD.

To date, there is no effective systemic therapy for spinal metastases, and the goal of treatment is to achieve local control of the tumor. Despite advances in radiation therapy, there is still a subgroup of patients that cannot be effectively treated with radiation because of close proximity of the tumor to the spinal cord. In addition, in cases of recurrent tumors, some patients cannot be re-treated because they reached the maximum allowed radiation dose. Surgery is the alternative treatment for these patients, but some tumors do recur after surgery while some patients have comorbidities that make surgery a high-risk procedure.

Based on our prior experience with selective IA chemotherapy for the treatment of ocular retinoblastoma and the high local control rates achieved with selective IA injection of chemotherapy in recurrent limb melanoma (limb infusion and limb perfusion) we expect that spinal intra-arterial chemotherapy with selective injection of Melphalan in the arteries feeding the metastatic disease is feasible and safe and may prove beneficial in achieving local control of the spinal tumor, preventing neurological compromise from cord compression. This minimally invasive approach can be used in patients in whom radiation therapy and surgery are contra-indicated and essentially have no other treatment options.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression	NCT03655080	Cord Compressio...	Radiation thera... nab-Paclitaxel	18 Years -	Washington University School of Medicine
Intra-arterial Chemotherapy for Spinal Metastases	NCT01637766	Spinal Diseases Spinal Metastas... Spinal Tumors	Melphalan (intr...	18 Years - 80 Years	Weill Medical College of Cornell University

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