153Sm-DOTMP for Cancer Metastasis to Bones
(SOLACE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called 153Sm-DOTMP, a type of radiopharmaceutical, to determine if it can safely help individuals with painful cancer that has spread to their bones. The goal is to understand how the body processes this treatment, its effects on radiation, and its potential to reduce pain. The trial seeks participants with bone cancer causing significant pain and whose disease has progressed despite other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Is there any evidence suggesting that 153Sm-DOTMP is likely to be safe for humans?
Research has shown that 153Sm-DOTMP, a treatment tested for cancer that has spread to the bones, was safe in earlier studies. In one study, a similar treatment called 153Sm-EDTMP reduced pain in patients with bone cancer. Most patients experienced less pain within a week, and the treatment was generally well-tolerated. Another study found that patients treated with 153Sm lived for an average of 18 months, suggesting it could be a manageable treatment option.
While these results are encouraging, it is important to note that this is an early-stage trial. Researchers are still closely examining the treatment's safety for people. Safety information from these early trials helps determine how the body reacts to the treatment and what doses are safe. Those considering joining the trial should consult a healthcare professional for more insight into what to expect.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for cancer metastasis to bones, which often include bisphosphonates or radiation therapy, 153Sm-DOTMP is unique because it specifically uses a radiopharmaceutical approach to target bone metastases. This treatment involves a radioactive isotope, Samarium-153, which is designed to deliver radiation directly to the cancerous areas within the bones, potentially minimizing damage to surrounding healthy tissues. Researchers are excited about 153Sm-DOTMP because its targeted action may offer more effective pain relief and better control of bone metastases compared to conventional methods, possibly improving the quality of life for patients.
What evidence suggests that 153Sm-DOTMP might be an effective treatment for bone metastases?
Research has shown that 153Sm-DOTMP, the treatment under study in this trial, may relieve bone pain caused by cancer spreading to the bones. One study demonstrated that a similar treatment, 153Sm-EDTMP, completely relieved pain in 46% of patients and reduced pain in 39%, achieving an 85% overall response rate. Many patients experienced pain relief within a week of treatment. These findings suggest that 153Sm-DOTMP could also effectively reduce bone pain from cancer. While these results are encouraging, further research is needed to confirm its effectiveness.23678
Who Is on the Research Team?
Namrata Chand
Principal Investigator
Telix Pharmaceuticals (Innovations) Pty Limited
Are You a Good Fit for This Trial?
This trial is for patients with confirmed cancer that has spread to their bones, causing significant pain. They must have a certain level of hemoglobin, kidney function (CrCl ≥30 mL/min), and liver function (total bilirubin ≤1.5 × ULN). Their blood counts should be within specific ranges, and they need to have a life expectancy of at least 16 weeks with a Karnofsky performance status over 60%. Patients who've progressed despite treatment but aren't suitable for other therapies can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of TLX090-Tx (153SmDOTMP) for the treatment of metastatic bone pain
Follow-up
Participants are monitored for safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy
What Are the Treatments Tested in This Trial?
Interventions
- 153Sm-DOTMP
Trial Overview
The study tests TLX090-Tx (153Sm-DOTMP), focusing on its safety, how the body processes it, radiation dosimetry, and initial effectiveness in relieving bone pain from metastatic cancer. It's an early phase open label study where all participants receive the investigational drug.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Dose Escalation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Telix Pharmaceuticals (Innovations) Pty Limited
Lead Sponsor
Citations
Treatment efficacy of 153Sm-EDTMP for painful bone ...
In our study complete response was achieved in 13 cases (46%); however 39% also showed some degrees of pain relief. This results in an 85% over all response.
Real World Safety, Survival Rate, and Effectiveness of ...
The results of this study indicate that the median time to death following Samarium-153 (153Sm) treatment was 18 months and the 5-year survival ...
Palliation of pain associated with metastatic bone cancer ...
A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration.
Comparative Therapeutic Efficacy of 153 Sm-EDTMP and ...
In the present study, we evaluated the comparative therapeutic efficacy of 153Sm-EDTMP and 177Lu-EDTMP for bone pain palliation in prostate and breast cancer ...
153Sm-EDTMP for Pain Relief of Bone Metastases from ...
We conclude that 153Sm-EDTMP was an adequate palliative agent and was the best option for our Mexican patients to relieve their severe metastatic bone pain.
A Dose Finding Study to Treat Bone Tumor(s)
This is an open-label, unblinded, multi-center, dose-finding study of 153-Sm-DOTMP (CycloSam®), a radiopharmaceutical that delivers radiation to the bone when ...
Acute radiotoxicity studies and safety assessment of 166Ho ...
In comparation, 153Sm-EDTMP injection, the absorbed dose ratio between red bone marrow and trabecular bone was 46% (1.86 and 2.32 mGy/MBq, respectively), while ...
Lexidronam Samarium Sm 153 - an overview
153Sm EDTMP is defined as a radionuclide used for bone palliation, demonstrating a pain relief response rate of 59% to 86% in patients with cancer-related pain, ...
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