Interleukin-2 + Dacarbazine for Melanoma

(DTIC Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Louisville

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Second cancer, Brain disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 30 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two FDA-approved cancer drugs, Dacarbazine (DTIC-Dome or Imidazole Carboxamide) and a low dose of Proleukin (Interleukin-2), to determine if they treat melanoma more effectively and with fewer side effects than current treatments. Melanoma, a type of skin cancer, is the focus, particularly in individuals with high-risk melanoma, where the cancer may be deeper or have spread to nearby lymph nodes. Eligible participants include those who have undergone surgery to remove the melanoma and meet specific conditions, such as having deep or recurring melanoma. The trial seeks a better treatment option for those facing these challenging melanoma cases. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering hope for improved outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you must not have active medical or psychiatric disorders requiring therapy that would prevent completion of the protocol, which might imply some restrictions. It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Interleukin-2 (IL2) and Dacarbazine (DTIC) together is generally safe for treating melanoma. The FDA has already approved both drugs for this use. Earlier studies found no unexpected side effects when these drugs were combined, indicating that most people tolerate the treatment well. While side effects can occur, they are usually neither surprising nor severe based on past results with these drugs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for melanoma?

Researchers are excited about combining Interleukin-2 with Dacarbazine for melanoma because it offers a novel approach to treatment. Unlike standard therapies that often rely on targeting the tumor directly, Interleukin-2 stimulates the body's immune system to attack cancer cells, potentially leading to a more robust and sustained response. Dacarbazine, a chemotherapy drug, works by damaging the DNA of cancer cells, and when used alongside Interleukin-2, it may enhance the overall effectiveness against melanoma. This combination targets melanoma in a unique way, harnessing both the immune system and direct chemotherapy effects, which could lead to improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for melanoma?

Research has shown that using Interleukin-2 (IL2) and Dacarbazine (DTIC) together can be promising for treating melanoma. In this trial, participants will receive the combination of IL2 and DTIC. Studies have found that this combination can help patients remain cancer-free for longer periods. IL2 boosts the immune system to fight cancer cells, while DTIC directly kills the cancer cells. Previous evidence suggests that this treatment might be less harmful than other options, making it a more manageable choice for people with high-risk melanoma. ^{3 6 7 8 9}

Who Is on the Research Team?

Jason Chesney, MD

Principal Investigator

James Graham Brown Cancer Center, University of Louisville

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

More than one group of my lymph nodes is affected.

You have a serious brain or mental condition that would prevent you from taking part in the study.

My melanoma was not fully removed or has spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of Dacarbazine (DTIC) and low-dose Proleukin (IL2) as adjuvant therapy for melanoma

30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dacarbazine
• Proleukin

Trial Overview 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.

How Is the Trial Designed?

Group I: Proleukin/DTIC Arm Experimental Treatment 1 Intervention

Adjucant proleukin and DTIC

Dacarbazine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Dacarbazine for:

• Hodgkin lymphoma
• Melanoma
• Soft tissue sarcoma

Approved in European Union as Dacarbazine for:

• Hodgkin lymphoma
• Melanoma
• Soft tissue sarcoma

Approved in Canada as Dacarbazine for:

• Hodgkin lymphoma
• Melanoma
• Soft tissue sarcoma

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

James Graham Brown Cancer Center

Collaborator

Trials

44

Recruited

9,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00553618

Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC ... The purpose of this study is to see if the combination of the two cancer drugs, Dacarbazine (DTIC) and a low-dose of Proleukin (IL2), would provide a less toxic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2363865/

Dacarbazine and interferon α with or without interleukin 2 in ... This study was designed to compare the efficacy of therapy with dacarbazine (DTIC) and interferon α (IFN-α) only to that of therapy with DTIC and IFN-α with ...

3. llusurgonc.org llusurgonc.org/images/DOWNLOADS/SENTINEL_ARTICLE/Melanoma/Metastatic/IL-2-Metastatic-Melanoma-JCO-1999.pdf

IL-2-Metastatic-Melanoma-JCO-1999.pdf Patients and Methods: Two hundred seventy assess- able patients were entered onto eight clinical trials conducted between 1985 and 1993. IL-2 (Proleukin.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.e21076

Interleukin-2 (IL-2) and 5-(3,3-dimethyle-1-triazeno) ... We analyze the recurrence free survival (RFS), overall survival (OS), and toxicity profile of Interleukin-2 (IL-2) and 5-(3,3-Dimethyle-1- ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804904004009

Review Re-evaluating the role of dacarbazine in metastatic ... Meta-analysis of published trial data demonstrate significant improvements in relapse-free survival across all doses, with borderline effects upon overall ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00553618

Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC ... Importantly, no unanticipated side effects were observed as a result of the combination of these two drugs (both of which are FDA-approved for use in melanoma ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3228046/

Systematic Review of Medical Treatment in Melanoma A systematic literature review of treatments for advanced, metastatic disease was conducted to present the success of current treatments.

8. aacrjournals.org aacrjournals.org/clincancerres/article/17/24/7732/205151/A-Dose-Escalation-and-Signal-Generating-Study-of

A Dose-Escalation and Signal-Generating Study of the ... Here, we report safety and activity results of the L19-IL2/dacarbazine combination therapy in 32 patients with metastatic melanoma. The clinical development of ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378608010320459

Cytostatic and cytotoxic drugs This chapter is devoted to a review of the monofunctional alkylating agents dacarbazine and temozolomide.