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Radium-224 Adsorbed In Calcium Carbonate Microparticles

Radspherin, a novel drug containing Radium-224 adsorbed in calcium carbonate microparticles, is currently being studied in clinical trials for the treatment of peritoneal cancer. These trials aim to evaluate the efficacy and safety of Radspherin as an intraperitoneal α-emitting radionuclide therapy in patients with peritoneal metastases from colorectal cancer and advanced ovarian, fallopian tube, or primary peritoneal cancer. The studies focus on patients undergoing various treatments, including cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, and neoadjuvant chemotherapy.

Table of Contents

What is Radspherin?

Radspherin is an innovative medical treatment currently being studied for patients with certain types of cancer that have spread to the lining of the abdominal cavity, a condition known as peritoneal carcinomatosis. It is classified as an intraperitoneal α-emitting radionuclide therapy, which means it uses radioactive particles to target cancer cells within the abdominal cavity.[1][2]

How Does Radspherin Work?

Radspherin contains a radioactive substance called radium-224 that is attached to tiny particles of calcium carbonate. When injected into the abdominal cavity, these particles can deliver targeted radiation to cancer cells. The radiation emitted by radium-224 is in the form of alpha particles, which have a very short range but high energy, potentially allowing for effective treatment of cancer cells while minimizing damage to surrounding healthy tissue.[1][2]

What Conditions Does Radspherin Treat?

Radspherin is being investigated for the treatment of peritoneal carcinomatosis arising from different types of cancer, including:

  • Colorectal cancer that has spread to the peritoneum (the lining of the abdominal cavity)[1]
  • Advanced ovarian cancer, including high-grade serous or high-grade endometrioid epithelial ovarian cancer[2]
  • Fallopian tube cancer with peritoneal metastasis[2]
  • Primary peritoneal cancer[2]

Ongoing Clinical Trials

Radspherin is currently being studied in Phase 2 clinical trials. These trials are designed to evaluate how well the treatment works and how safe it is compared to standard treatments. Two main studies are ongoing:

  1. A study for patients with peritoneal carcinomatosis from colorectal cancer who have undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC)[1]
  2. A study for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who are scheduled to undergo neoadjuvant chemotherapy and interval debulking surgery[2]

Potential Benefits

The clinical trials aim to determine if Radspherin can provide benefits such as:

  • Improved progression-free survival (the time without cancer growth or spread)[1][2]
  • Increased overall survival[1][2]
  • Better quality of life for patients[1][2]
  • Delayed need for subsequent cancer treatments[2]

Eligibility for Treatment

Eligibility for Radspherin treatment in these clinical trials typically includes:

  • Confirmed diagnosis of the specific cancer types being studied
  • Presence of peritoneal metastases that can be surgically removed
  • Adequate organ function (kidney, liver, and bone marrow)
  • Good overall health status (ECOG Performance Status of 0 to 2)
  • Age 18 years or older

Patients with certain conditions may not be eligible, such as those with active infections, other recent cancers, or specific genetic mutations (in the case of the ovarian cancer study).[1][2]

Administration and Dosage

Radspherin is administered as an intraperitoneal injection, which means it is injected directly into the abdominal cavity. The maximum dose being studied is 7 MBq (megabecquerels, a unit of radioactivity). The treatment is typically given as a single dose, although the exact timing and integration with other treatments may vary depending on the specific clinical trial.[1][2]

Safety and Side Effects

As Radspherin is still in clinical trials, its full safety profile is not yet established. The ongoing studies are carefully monitoring for any side effects or complications. Patients receiving Radspherin will be closely observed for:

  • Changes in blood cell counts
  • Liver and kidney function
  • Surgical complications
  • Any other adverse events

Due to the radioactive nature of the treatment, special precautions are necessary, including the use of effective contraception for both male and female patients for a period after treatment.[1][2]

Conclusion

Radspherin represents a promising new approach to treating peritoneal carcinomatosis from various types of cancer. By delivering targeted radiation directly to cancer cells within the abdominal cavity, it may offer a new option for patients who have limited treatment choices. However, as it is still in clinical trials, more research is needed to fully understand its effectiveness and safety profile. Patients interested in this treatment should discuss with their oncologist whether participating in a clinical trial might be appropriate for their specific situation.

Aspect Colorectal Cancer Trial Ovarian Cancer Trial
Study Phase Phase 2 Phase 2
Patient Population Peritoneal metastases from colorectal carcinoma Primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
Primary Endpoint Progression-free survival (PFS) Progression-free survival (PFS)
Key Secondary Endpoints Overall survival (OS), Peritoneal PFS, Quality of Life Overall survival (OS), Peritoneal PFS, Time to subsequent therapies
Treatment Context After cytoreductive surgery and HIPEC After neoadjuvant chemotherapy, before interval debulking surgery
Dosage Up to 7 MBq Up to 7 MBq
Administration Route Intraperitoneal Intraperitoneal
Key Inclusion Criteria ECOG 0-1, adequate organ function ECOG 0-2, HR proficient, completed 3-4 cycles of NACT
Key Exclusion Criteria Other metastases, recent pelvic radiation BRCA mutations, liver disease, bevacizumab treatment

FAQ

  • What is Radspherin and how does it work? Radspherin is a drug containing Radium-224 adsorbed in calcium carbonate microparticles. It is an α-emitting radionuclide therapy designed to be administered intraperitoneally (directly into the abdominal cavity) to target and treat peritoneal cancer metastases.
  • What types of cancer are being studied in these clinical trials? The clinical trials are focusing on peritoneal metastases from colorectal cancer and primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • What is the main objective of these clinical trials? The main objective of these trials is to compare progression-free survival (PFS) in patients receiving Radspherin treatment versus those not receiving the treatment. This will help determine if Radspherin is effective in prolonging the time before cancer progresses or returns.
  • How is Radspherin administered to patients? Radspherin is administered intraperitoneally, which means it is injected directly into the abdominal cavity. This method allows the drug to target cancer cells that have spread within the peritoneal area.
  • What are some of the key eligibility criteria for these trials? Key eligibility criteria include having confirmed peritoneal metastases, being fit enough for surgery, having adequate organ function, and not having certain exclusionary conditions like active infections, symptomatic central nervous system metastases, or recent treatment with other investigational drugs. Specific criteria may vary between the colorectal and ovarian cancer trials.

Ongoing Clinical Trials on Radium-224 Adsorbed In Calcium Carbonate Microparticles

  • Study of Radium-224 in Patients with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer with Peritoneal Metastasis Undergoing Chemotherapy and Surgery

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Norway Spain

  • Study of Radspherin® for Patients with Peritoneal Cancer from Colorectal Cancer After Surgery and Chemotherapy

    Not yet recruiting

    2 1 1
    Investigated drugs:
    The Netherlands Norway Sweden

Glossary

  • Peritoneal carcinomatosis: A condition where cancer cells spread throughout the peritoneum, the thin layer of tissue that lines the abdominal cavity and covers most of the abdominal organs.
  • Cytoreductive surgery (CRS): A surgical procedure to remove visible tumors from the abdominal cavity in patients with peritoneal carcinomatosis.
  • Hyperthermic intraperitoneal chemotherapy (HIPEC): A cancer treatment that involves filling the abdominal cavity with heated chemotherapy drugs after cytoreductive surgery to kill any remaining cancer cells.
  • Neoadjuvant chemotherapy (NACT): Chemotherapy given before the main treatment (usually surgery) to shrink the tumor and make the primary treatment more effective.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • RECIST: Response Evaluation Criteria in Solid Tumours, a set of rules used to measure how well a cancer patient responds to treatment.
  • Homologous recombination (HR) proficient: Refers to cancer cells that have normal DNA repair mechanisms, which can affect how they respond to certain treatments.
  • Interval debulking surgery (IDS): A surgical procedure performed after initial chemotherapy to remove as much of the remaining tumor as possible in ovarian cancer patients.
  • Biomarkers: Measurable indicators in the body that can be used to assess the presence or progress of a disease, such as CEA, CA19-9, CA125 for cancer.

References

  1. http://clinicaltrials.eu/trial/study-of-radspherin-for-patients-with-peritoneal-cancer-from-colorectal-cancer-after-surgery-and-chemotherapy/
  2. http://clinicaltrials.eu/trial/study-of-radium-224-in-patients-with-advanced-ovarian-fallopian-tube-or-peritoneal-cancer-with-peritoneal-metastasis-undergoing-chemotherapy-and-surgery/