Could a blood pressure drug help fight melanoma?
NCT ID NCT01009177
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested whether adding bosentan, a drug used for blood vessel conditions, to standard chemotherapy (dacarbazine) could slow tumor growth in people with stage IV melanoma. The study enrolled 80 adults with advanced melanoma and compared the combination to chemotherapy alone. The main goal was to see how long patients lived without their cancer getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bosentan
- What this could lead to
- If successful, this could point toward a new combination treatment to slow tumor growth in advanced melanoma.
- What could go wrong
- This is an early Phase 2 trial with only 80 participants, so results may not be conclusive. Bosentan is already used for other conditions and may not improve outcomes in melanoma.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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80 people
The number who actually took part.
- Started
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Sep 2005
- Finished
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Feb 2008
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients 18 years of age or older 2. Histologically proven malignant melanoma (Balch et al., J. Clin Oncol. 19(16): 3635-48, 2001) with stage IV measurable disease as defined by RECIST criteria (Therasse et al., J Natl Cancer Inst, 92(3): 205-16, 2000). 3. Patients with prior radiation therapy (\> 30 days prior to study drug initiation) will be allowed provided the indicator lesion(s) used for this study was (were) outside the field of radiation or represent new lesions not previously irradiated. 4. Patients who had no prior therapy with DTIC. 5. Patients with cutaneous melanoma lesions must consent to having a biopsy obtained during the screening period and at the end of treatment for exploratory analysis of endothelin receptor expression. Biopsies obtained prior to the study that have been frozen in accordance with procedures specified for this protocol may be used. 6. ECOG performance status (≤ 2) 7. Life expectancy \> 12 weeks 8. Female patients must be non-pregnant, non-breast feeding, and either post menopausal, surgically sterile, or practicing a reliable method of contraception (hormonal methods alone are not sufficient) 9. Provide written informed consent 10. Willing to return to study center for follow up Exclusion Criteria: 1. ALT and/or AST \> 3 × the upper limit of normal (ULN) at screening OR ALT and /or AST \> 2 x ULN and total bilirubin \> 2.0 mg/dl at screening 2. Lactate dehydrogenase \> 1.5 x ULN 3. Hemoglobin \>30% below the lower limit of normal 4. Systolic blood pressure \< 85 mmHg 5. NYHA class III/IV congestive heart failure 6. Any prior chemotherapy, biological therapy or immunotherapy for stage IV metastatic disease. 7. Received immunotherapy \< 30 days before treatment start (completed adjuvant immunotherapy for previous resected metastatic disease is allowed) 8. Concurrent use of calcineurin inhibitors (cyclosporine A, tacrolimus), sirolimus, fluconazole or glibenclamide (glyburide) or expected to receive any of these drugs during the study at inclusion and during the study. 9. History of other malignancy in the last 5 years, with the exception of squamous cell carcinoma of the skin treated with local resection and basal cell carcinoma 10. CNS metastases or carcinomatous meningitis 11. Ocular melanoma 12. Known hypersensitivity to any excipients of Tracleer™ 13. Prior therapy with bosentan 14. Use of therapy with another investigational drug within 4 weeks of the start of dosing with bosentan or plan to receive such treatment during the study 15. Known drug or alcohol dependence or any other factor that will interfere with the conduct of the study 16. Any standard contraindications for the use of DTIC as per Australian package insert
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barwon Health - The Geelong Hospital
Geelong, VIC 3220, Australia
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Cabrini Hopsital - Oncology Department
Malvern, VIC 2144, Australia
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Mater Adult Hospital
South Brisbane, QLD 4001, Australia
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Mount Medical Centre
Perth, WA, Australia
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New Castle Melanoma Unit
Newcastle, NSW, Australia
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Pacific Private Clinic
Southport, QLD 4215, Australia
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Redcliffe Hospital - Dept Oncology & Palliative Care
Redcliffe, QLD 4020, Australia
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Royal North Shore Hospital
St Leonards, NSW, Australia
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Southern Medical Day Care Centre
Wollongong, NSW, Australia
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Sydney Cancer Centre, Royal Prince Alfred Hospital
Sydney, NSW, Australia
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Sydney Haematology and Oncology Unit
Hornsby, NSW, Australia
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Westmead Hospital - Department of Oncology
Westmead, NSW 2145, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?