Experimental drug shows promise for tough skin cancer
NCT ID NCT00249262
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a weekly injection of a new chemotherapy drug called Taxoprexin in 30 people with advanced melanoma that had spread to other parts of the body. The goal was to see if the drug could shrink tumors and how long that effect might last. Researchers also monitored side effects and overall survival. Participants had not received chemotherapy before for their metastatic disease.
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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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30 people
The number who actually took part.
- Start date
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Oct 2005
- Finished
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Apr 2007
- 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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13 years and older
- 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. Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease. 2. Patients must have at least one measurable lesion. 3. Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed. 4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy. 5. At least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow and prior adjuvant chemotherapy. 6. Patients must have Eastern Cooperative Oncology Group performance status of 0-2. 7. Patients must be \> 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients. 8. Patients must have adequate liver and renal function. 9. Patients must have adequate bone marrow function. 10. Life expectancy of at least 3 months 11. Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution. Exclusion Criteria: 1. Patients who have received prior therapy with any taxane. 2. Patients whose primary site was the choroid (eye). 3. Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years. 4. Patients with symptomatic brain metastasis (es). 5. Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study. 6. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals). 7. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1). 8. Patients with unstable or serious concurrent medical conditions are excluded. 9. Patients with a known hypersensitivity to Cremophor.
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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.
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Other studies related to the condition(s) this trial covers.
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