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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the study duration is projected to be approximately 9 years

Awards & highlights

DTIC Trial 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.Check my eligibility

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.See study design

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.

DTIC Trial 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.

DTIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the study duration is projected to be approximately 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the study duration is projected to be approximately 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and the study duration is projected to be approximately 9 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relapse-free survival

DTIC Trial Design

1Treatment groups

Experimental Treatment

Group I: Proleukin/DTIC ArmExperimental Treatment1 Intervention

Adjucant proleukin and DTIC

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,824 Total Patients Enrolled

9 Trials studying Melanoma

247 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA acknowledged the efficacy of Proleukin and Dacarbazine?

"While there is some data supporting the safety of Proleukin and Dacarbazine, it is only from Phase 2 trials. This means that there is no evidence that the medication is effective."

Answered by AI

Are there any similar treatments to Proleukin and Dacarbazine?

"At present, there are 96 ongoing clinical trials investigating the efficacy of Proleukin and Dacarbazine. Of those, 15 are Phase 3 trials. The majority of these studies are based in Boston, but there are 1,349 locations across the globe conducting these trials."

Answered by AI

Are there still vacancies in this experimental program?

"Unfortunately, this particular study is not presently searching for new candidates. Although, it is worth noting that the trial was first posted on 8/1/2007 and was last edited on 10/22/2021. There are 792 other studies actively looking for patients with melanoma and 96 studies for Proleukin and Dacarbazine that are enrolling patients."

Answered by AI

What do Proleukin and Dacarbazine help to treat?

"Proleukin and Dacarbazine are commonly used to treat metastatic melanoma. They can also be effective in treating pheochromocytomas, metastatic renal cell carcinoma ( mrcc), and adrenal medulla."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients

Jason Chesney 2007. "Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00553618.