Melanoma Treatment Trials
Allovectin-7® versus Dacarbazine (DTIC) or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma (SLHN 2007-05; Vical LX01-315)
Purpose
The purpose of this study is to compare the safety and results of Allovectin-7® versus Dacarbazine (DTIC) or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.
Further Study Information
Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial, all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.
Eligibility Criteria
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Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
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At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
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At least 18 years old and able and willing to provide informed consent to participate
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No previous chemotherapy treatment for melanoma
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No melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
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Patients may not participate if surgical removal of all lesions would be possible and could be curative
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May not have any melanoma tumors greater than 10cm x 10cm in size
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Final eligibility is determined by the research staff
Use of OncoVEXGM-CSF to Treat Patients with Melanoma (SLHN 2008-72; BioVex 005/05 Melanoma)
Purpose
This study is being conducted to learn about the safety and risks of using OncoVEXGM-CSF to treat patients with melanoma and to see if OncoVEXGM CSF can destroy these tumors compared to GM-CSF. This study may provide information on the usefulness of OncoVEXGM-CSF as a future treatment for melanoma. This study may also provide information on the safety and usefulness of GM-CSF as compared to OncoVEXGM-CSF as a treatment for melanoma.
Eligibility Criteria
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Males or females age 18 years or older
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Received at least 1 prior non-surgical therapy for active disease (e.g. chemotherapy, radiation, biologic, or investigational treatment given as part of a clinical trial)
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Stage IIIb, IIIc or stage IV disease that is not surgically resectable (able to be completely removed through surgery)
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At least 1 injectable melanoma tumor greater than 10 mm in longest diameter or, multiple injectable melanoma tumors which in total have a longest diameter of greater than 10 mm
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No active brain metastases. Patients with up to 3 brain metastases may be enrolled, provided that all tumors have been properly treated with stereotactic radiation therapy or gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two months prior to patient’s assignment to their study drug.
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No spread of cancer to the bone
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Limited number of metastases in other organs (for example, the liver)
Final eligibility is determined by the research staff.
Effectiveness of Ipilimumab Preventing or Delaying Recurrence of High Risk Stage III Melanoma (SLHN 2008-24; BMS 184-029/EORC 18071)
Purpose
The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection (removal through surgical procedure) of high risk stage III melanoma.
Eligibility Criteria
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Older than 18 years of age
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Complete and adequate resection of Stage III melanoma with confirmed melanoma metastatic (spreading) to lymph node
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Disease-free
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Must start study drug within 12 weeks of surgery
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No prior therapy for melanoma except surgery
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No auto-immune disease
Study of Effectiveness of ABI-007 vs. Dacarbazine in Patients with Metastatic Melanoma (SLHN 2009-20; Abraxis CA033 Melanoma)
Purpose
The main purpose of this research study is to compare the differences in how well a test drug, ABI-007, performs in maintaining safety, working without causing side effects, and acting against tumors, versus the drug Dacarbazine in patients with metastatic (spreading) melanoma who have not yet received chemotherapy. ABI-007 is a new arrangement of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer.
Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.
Eligibility Criteria
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Must have a confirmed melanoma tumor on the skin with evidence of metastasis (Stage IV).
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No prior chemotherapy for metastatic melanoma is permitted. Prior treatment with certain immune therapies is allowed.
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Must be 18 years of age or older.
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No other current active cancer within the past 3 years.
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Tumor must be of a size measurable through X-ray or scans.
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No history of or current evidence of spread of cancer to the brain.
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Prior radiation to a specific cancerous area is permitted only if there has been clear progression of the cancerous area since radiation was completed.
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No other significant illness which would make it unsafe to participate.
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May not participate in another investigational study at the same time.
Final eligibility is determined by the research staff.
Randomized study of four weeks high-dose IFN-a2b in stage II-A melanoma (E1697)
Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.
Purpose
Randomized phase III trial to determine the effectiveness of high-dose interferon alfa in treating patients who have stage II or stage III melanoma that has been completely removed surgically.
Eligibility
- At least 18 years old
- No previous biological therapy, chemotherapy or radiation therapy
Treatment Intervention
Patients will be randomly assigned to one of two groups.
- Patients in group one will undergo observation only.
- Patients in group two will receive infusions of interferon alfa five days a week for four weeks.
Quality of life will be assessed periodically. Patients will receive follow-up evaluations every three months for two years, every six months for three years and once a year thereafter.
Phase II study of low-dose PEG-Interferon alfa-2b in patients with metastatic melanoma over-expressing basic fibroblast growth factor (ECOG 2602)
Biological therapies such as PEG-interferon alfa-2b use different ways to stimulate the immune system and stop cancer cells from growing.
Purpose
Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.
Eligibility
- At least 18 years old
- Measurable disease(can be seen on an X-ray or scan)
- No spread of cancer to the brain
- At least four weeks since interferon
Treatment Intervention
Patients will receive an injection of PEG-interferon alfa-2b once a week for approximately one year. Patients will be evaluated every three months for two years and every six months for one year.