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Alkylating agent
Interleukin-2 + Dacarbazine for Melanoma (DTIC Trial)
Phase 2
Waitlist Available
Led By Jason A Chesney, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must fulfill specific criteria related to the depth and metastasis of the melanoma
Patients must have undergone wide excision of the primary melanoma and, if >1mm in depth, have completed sentinel lymph node sampling or lymphadenectomy
Must not have
Patients with more than one lymph node group involved
Patients with evidence of incompletely resected melanoma or distant metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a combination of two existing cancer drugs is more effective and less toxic than current treatments for people with high-risk melanoma.
Who is the study for?
This trial is for adults aged 18-85 with high-risk melanoma who've had surgery to remove the cancer and, if needed, lymph node procedures. They must be in good physical condition with no serious medical or mental health issues and not pregnant. Participants need normal blood counts and organ function, can't have had previous melanoma treatments or other active cancers.
What is being tested?
The study tests a combination of two FDA-approved drugs, Dacarbazine (DTIC) and Proleukin (IL2), to see if they're more effective together for treating high-risk melanoma than existing options. The goal is to find a treatment that's less toxic but still powerful against this skin cancer.
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, nausea, vomiting, diarrhea, skin rash or itching. There may also be changes in blood pressure or heart rate due to Proleukin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma has specific characteristics regarding its depth and spread.
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I had surgery to remove my melanoma and, if it was deep, also had lymph node surgery.
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I have had the tip of my finger or toe removed due to nail bed cancer.
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I am between 18 and 85 years old.
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I can take care of myself and am up and about more than half of the day.
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I don't have any health or mental conditions that would stop me from completing the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
More than one group of my lymph nodes is affected.
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My melanoma was not fully removed or has spread to distant parts of my body.
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I do not have an active second cancer, except for certain skin cancers or cervical cancer in situ.
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I am of childbearing age and not using effective birth control.
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I had chemotherapy or immunotherapy for melanoma before it spread to my lymph nodes.
Select...
My melanoma tests came back negative for cancer cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Proleukin/DTIC ArmExperimental Treatment1 Intervention
Adjucant proleukin and DTIC
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
346 Previous Clinical Trials
77,405 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,036 Total Patients Enrolled
Jason A Chesney, MDPrincipal InvestigatorJames Graham Brown Cancer Center, University of Louisville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious brain or mental condition that would prevent you from taking part in the study.More than one group of my lymph nodes is affected.My melanoma was not fully removed or has spread to distant parts of my body.My melanoma has specific characteristics regarding its depth and spread.I had surgery to remove my melanoma and, if it was deep, also had lymph node surgery.I have had the tip of my finger or toe removed due to nail bed cancer.I am between 18 and 85 years old.I can take care of myself and am up and about more than half of the day.I don't have any health or mental conditions that would stop me from completing the study.I do not have an active second cancer, except for certain skin cancers or cervical cancer in situ.I am of childbearing age and not using effective birth control.I had chemotherapy or immunotherapy for melanoma before it spread to my lymph nodes.My melanoma tests came back negative for cancer cells.Your blood tests must show certain levels of cells and chemicals.
Research Study Groups:
This trial has the following groups:- Group 1: Proleukin/DTIC Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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