QUADRAMET SUMMARY
QUADRAMET® is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET® is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration. QUADRAMET® does not contain a preservative. Each milliliter contains 35 mg EDTMP•H2O, 5.3 mg Ca [as Ca(OH)2], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.
QUADRAMET® is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
|
NEWS HIGHLIGHTSMedia Articles Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)
62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain
Source: Health News from Medical News Today [2009.11.19]
St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.
Common Pain Relief Medication May Encourage Cancer Growth
Source: Cancer / Oncology News From Medical News Today [2009.11.19]
Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
FDA Approves New Drug For Pain That Persists After Shingles
Source: Dermatology News From Medical News Today [2009.11.18]
The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. The medicated skin patch, which is made by Lohmann Therapie-Systems AD of Andernach, Germany and distributed in the US by NeurogesX Inc.
Published Studies Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)
[Cost-effectiveness analysis of samario-153 (Quadramet) for the treatment of patients with prostate cancer and bone metastases] [2005.06]
CONCLUSION: Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.
A comparative study of samarium-153-ethylenediaminetetramethylene phosphonic acid with pamidronate disodium in the treatment of patients with painful metastatic bone cancer. [2003.04]
CONCLUSION: The data showed that the therapeutic efficacy of (153)Sm-EDTPM was higher than that of pamidronate disodium (for pain relief maintained more than 3 weeks) and its incidence of blood toxicity was also higher than that of pamidronate disodium. Copyright 2003 S. Karger AG, Basel
Multicentre trial on the efficacy and toxicity of single-dose samarium-153-ethylene diamine tetramethylene phosphonate as a palliative treatment for painful skeletal metastases in China. [1999.01]
A multicentre trial was organized in China as part of an international coordinated research project to study the efficacy and toxicity of single-dose samarium-153 ethylene diamine tetramethylene phosphonate (EDTMP) as a palliative treatment for painful skeletal metastases... Further studies are needed to identify better ways of determining the appropriate dose in the individual case and the efficacy of treatment.
Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. [1998.04]
PURPOSE: To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study... CONCLUSION: 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 and persisted until at least week 16 in the majority of patients who responded.
Background, reasons and benefits using the vienna protocol for the treatment of painful bone recurrences with 153Samarium-EDTMP. [2009.08]
153Samarium-ethylendiaminetetramethylenephosphonate (EDTMP) has become a treatment of choice for painful bone recurrences...
Clinical Trials Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)
Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases [Recruiting]
Primary objectives:
- To determine the time to progression in subjects with breast cancer metastatic to bone
only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation
(PBSCT).
Secondary objectives:
- To determine the overall survival at one year.
- To determine the efficacy of 153Sm-EDTMP at 6 months.
- To assess pain in subjects treated with 153Sm-EDTMP.
- To determine the safety of 153Sm-EDTMP.
Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma [Active, not recruiting]
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry
radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth
of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood
flow to the cancer. Bortezomib may also make cancer cells more sensitive to radiation
therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more
cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when
given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in
treating patients with relapsed or refractory multiple myeloma.
Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain [Active, not recruiting]
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry
radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate
may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam
pentasodium together with zoledronic acid or pamidronate may be an effective treatment for
multiple myeloma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153
lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how
well it works in treating patients with relapsed or refractory multiple myeloma and bone
pain.
Samarium Sm 153 Lexidronam Pentasodium With or Without Vaccine Therapy in Treating Patients With Prostate Cancer and Bone Metastases [Recruiting]
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry
radiation directly to tumor cells and not harm normal cells. Vaccines made from a
gene-modified virus may help the body build an effective immune response to kill tumor
cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells
and platelets found in bone marrow or peripheral blood. Giving samarium Sm 153 lexidronam
pentasodium together with vaccine therapy and GM-CSF may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying samarium Sm 153 lexidronam pentasodium,
vaccine therapy, and GM-CSF to see how well they work compared to samarium Sm 153 lexidronam
pentasodium alone in treating patients with prostate cancer and bone metastases.
Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer [Recruiting]
The purpose of this study is to investigate the safety, tolerability and anti-tumor effects
of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with
castrate metastatic prostate cancer.
|
