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Cytokine
Arm I for Melanoma
Phase 2
Waitlist Available
Led By William Carson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 and interferon alfa may kill more tumor cells.
Eligible Conditions
- Melanoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS
Response rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment3 Interventions
Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Edodekin alfa
Not yet FDA approved
Benzalkonium
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,704 Previous Clinical Trials
40,931,382 Total Patients Enrolled
558 Trials studying Melanoma
193,382 Patients Enrolled for Melanoma
William CarsonPrincipal InvestigatorCancer and Leukemia Group B
4 Previous Clinical Trials
123 Total Patients Enrolled
1 Trials studying Melanoma
57 Patients Enrolled for Melanoma
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