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Welcome to the July issue of the Clinical Research Connection. We value the partnership we have with our affiliate network and hope this newsletter will provide an opportunity for enhanced communication and interaction, and advance our collective strength in the area of oncology research.
Please send your feedback and suggestions to Vera Jackson at affiliates@northwestern.edu.
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NU 07M3: In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma with Cutaneous Metastases
This is a single-center, prospective, open-label, phase-I study enrolling approximately 15 subjects with stage IV melanoma and treatable cutaneous metastases. It involves a new experimental treatment called "In-Situ Photoimmunotherapy" (ISPI) which is directed to treat skin metastases (tumors) in advanced stages of malignant melanoma and not the initial tumor. This type of treatment uses a laser device called "810-nm diode laser." This laser treatment is combined with a laser-absorbing dye called "indocyanine green 0.25% solution (ICG)" which is injected directly into the skin tumor. The laser produces destruction of the skin tumor cells. The deposits of tumor destroyed in this manner and left in place will serve to stimulate the immune system and may ultimately cure the tumor. This photothermal treatment (treatment that involves light and heat, which in this case is a laser) is used with an immunoadjuvant (a drug that enhances your immune system's response) called "imiquimod 5% cream (Aldara)," which is applied to the skin tumors. This cream, which stimulates immune responses in various other skin conditions, has also shown some beneficial effect in individual cases of advanced melanoma.
The primary objective of the study is to determine the safety of in-situ photoimmunotherapy (ISPI) in patients with metastatic melanoma with cutaneous metastases. It will look at the side effects of ISPI as well as the outcomes of people undergoing treatment with ISPI. ISPI is a promising modality for treatment of metastatic melanoma with cutaneous metastases; a disease that does not yet have a consistently effective therapy available. Cumulative five-year patient survival with conventional therapies is only about 18%, justifying the exploration this approach.
Participants in this study will be given imiquimod cream at their baseline visit. This is applied twice daily, 12 hours apart under saran wrap, for a total of 6 weeks. Two weeks and four weeks after the baseline visit, participants will be given a laser treatment. Using common skin numbing medications via an injection (1% lidocaine and epinephrine), the skin tumor areas selected for treatment will be numbed followed by injection of the ICG solution into the skin tumors, and 30 minutes later these areas will be treated with the laser. Lasers use an intense burst of light to heat the targeted tumor. Participants in this study will be seen at the Northwestern University Dermatology Clinic. Participation will last for 24 weeks and will involve 8 visits (including the screening visit) to the clinic and 2 follow-up telephone visits.
Some of the eligibility criteria include:
- Participants must be 18 or older.
- Participants must have histologically confirmed cutaneous metastatic malignant melanoma from any primary tumor site.
- Participants may not have had radiation to the skin within 4 weeks of entering this study.
Note: This is only a partial list of eligibility criteria. Please contact Vera Jackson at v-jackson2@northwestern.edu for additional information.
ECOG 1697: Phase III Randomized Study of Four Weeks High Dose Interferon-α2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) Melanoma
The purpose of this adjuvant study is to evaluate the effect of treatment on recurrence for patients with localized melanomas with negative lymph node involvement. The current standard of care for this study population is close observation, although 25-35% of patients will relapse within 5 years. High dose interferon has shown to be effective therapy for patients with more advanced melanomas. This trial will evaluate whether therapy will prevent recurrence or delay the time to recurrence in patients with localized melanoma.
Patients with localized melanoma will be randomized to high-dose interferon for 4 weeks or close observation. Patients randomized to high-dose interferon will receive therapy Monday through Friday in the outpatient clinic. Both groups of patients will be followed closely with bloods tests and exams.
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Drug 111482: A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of recMAGE-A3 + AS15 ASCI as Adjuvant Therapy in Patients with MAGE-A3 Positive Resected Stage III Melanoma
The purpose of this study is to evaluate the effect of treatment on recurrence in patients with Stage III melanoma with complete removal of involved lymph nodes and whose tumors are MAGE-A3 positive. The MAGE-A3 antigen is known to be over expressed on some cancers including melanoma tumor cells and therefore is a target for therapy. This study will evaluate the effect of combining the recombinant MAGE-A3 protein with the immune stimulant AS15 to stimulate the patient's immune system to identify and eliminate the melanoma tumor cells.
Patient's tumors will be tested for MAGE-A3 expression. Patients who are MAGE-A3 positive will be randomized to receive the recMAGE-A3 + AS15 ASCI or placebo. During the first part of the study, patients will receive the study treatment every 3 weeks until a total of 5 intramuscular injections have been given. During the second part of the study, patients will receive the study treatment every 3 months for 8 more injections. A total of 13 injections are planned, and the scheduled treatment will last a maximum of 27 months from the first to the last administration of study treatment. All patients will be followed closely with blood tests and exams.
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