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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

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 below

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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:

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Proleukin/DTIC ArmExperimental Treatment1 Intervention

Adjucant proleukin and DTIC

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

342 Previous Clinical Trials

77,173 Total Patients Enrolled

9 Trials studying Melanoma

243 Patients Enrolled for Melanoma

James Graham Brown Cancer CenterOTHER

43 Previous Clinical Trials

9,058 Total Patients Enrolled

6 Trials studying Melanoma

216 Patients Enrolled for Melanoma

Jason A Chesney, MDPrincipal InvestigatorJames Graham Brown Cancer Center, University of Louisville

Media Library

Dacarbazine (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT00553618 — Phase 2

Melanoma Research Study Groups: Proleukin/DTIC Arm

Melanoma Clinical Trial 2023: Dacarbazine Highlights & Side Effects. Trial Name: NCT00553618 — Phase 2

Dacarbazine (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00553618 — Phase 2

~7 spots leftby Aug 2025

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