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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR SODIUM THIOSULFATE

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Clinical Trials for Sodium Thiosulfate

Trial ID Title Status Sponsor Phase Summary
NCT00004547 Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy Completed National Cancer Institute (NCI) Phase 2 This study will test the effectiveness of an experimental treatment for peritoneal cancer involving surgical removal of the tumor, perfusion of the abdomen during surgery with a heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the abdomen with fluorouracil (5-FU) and paclitaxel. Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, electrocardiogram and possibly bone scan, brain magnetic resonance imaging (MRI), and chest, abdomen and pelvic CT scans. Participants undergo surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected. During surgery, after the tumor has been removed, two catheters (thin plastic tubes) are placed in the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a temperature of about 108.6 degrees (10 degrees above normal body temperature) is then delivered into the abdomen through one catheter and drained through another. During treatment, a drug called sodium thiosulfate is given through a vein to reduce the risk of side effects of cisplatin, particularly kidney damage. After 90 minutes of bathing the abdomen with this solution, the drug is rinsed from the abdomen and the catheters removed. Another small catheter is then placed and left inside the abdomen with one end coming out through the skin. Seven to 12 days after the operation, the anti-cancer drugs 5-FU and paclitaxel are given through this catheter. After complete recovery from the surgery, the catheter is removed and the patient is discharged from the hospital. Clinic visits are scheduled for periodic follow-up examination, imaging, and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long as the disease does not worsen. Patients whose disease progresses are taken off the study and referred back to their local physician or referred for alternative care or other research studies. Patients are also asked to assess how this therapy affects their general health and well being. This will require filling out two quality-of-life (QOL) questionnaires before surgery and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to complete.
NCT00074165 Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen Terminated National Cancer Institute (NCI) Phase 2 RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00074165 Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen Terminated OHSU Knight Cancer Institute Phase 2 RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00075387 Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors Recruiting National Cancer Institute (NCI) Phase 2 This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sodium Thiosulfate

Condition Name

Condition Name for Sodium Thiosulfate
Intervention Trials
Malignant Pleural Mesothelioma 4
Drug/Agent Toxicity by Tissue/Organ 3
Ototoxicity 3
Pleural Mesothelioma 3
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Condition MeSH

Condition MeSH for Sodium Thiosulfate
Intervention Trials
Calcinosis 7
Mesothelioma 6
Fever 5
Neoplasms 4
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Clinical Trial Locations for Sodium Thiosulfate

Trials by Country

Trials by Country for Sodium Thiosulfate
Location Trials
United States 73
Canada 8
Netherlands 2
United Kingdom 2
France 2
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Trials by US State

Trials by US State for Sodium Thiosulfate
Location Trials
Oregon 8
Massachusetts 5
Minnesota 5
Texas 5
Ohio 4
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Clinical Trial Progress for Sodium Thiosulfate

Clinical Trial Phase

Clinical Trial Phase for Sodium Thiosulfate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2 19
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Clinical Trial Status

Clinical Trial Status for Sodium Thiosulfate
Clinical Trial Phase Trials
Recruiting 10
Completed 10
Not yet recruiting 8
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Clinical Trial Sponsors for Sodium Thiosulfate

Sponsor Name

Sponsor Name for Sodium Thiosulfate
Sponsor Trials
National Cancer Institute (NCI) 10
OHSU Knight Cancer Institute 7
M.D. Anderson Cancer Center 4
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Sponsor Type

Sponsor Type for Sodium Thiosulfate
Sponsor Trials
Other 40
NIH 12
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Express Scripts
Colorcon
Fuji
Cipla
QuintilesIMS
Queensland Health
Fish and Richardson

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