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

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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 and more effective treatment for melanoma than currently available treatments for people with high-risk melanoma. Dacarbazine (DTIC) and Proleukin (IL2) are both FDA-approved drugs for the treatment of melanoma.

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.

What data supports the effectiveness of the drug combination of Interleukin-2 and Dacarbazine for treating melanoma?

Research shows that combining dacarbazine with interleukin-2 can lead to a response rate of about 15% in patients with metastatic melanoma, suggesting some effectiveness in shrinking tumors. ^{1 2 3 4 5}

Is the combination of Interleukin-2 and Dacarbazine safe for humans?

The combination of Interleukin-2 and Dacarbazine has been studied for safety in patients with melanoma. Some patients experienced skin reactions like rashes and scaling, and changes in drug levels in the body were observed, which suggests that the combination can affect how the drugs work together. These findings indicate that while the treatment is generally used in humans, it can have side effects that should be monitored. ^{1 2 6 7 8}

How is the drug combination of Interleukin-2 and Dacarbazine unique for treating melanoma?

The combination of Interleukin-2 (IL-2) and Dacarbazine (DTIC) for melanoma is unique because it combines chemotherapy with immunotherapy, aiming to enhance the body's immune response against cancer cells while directly targeting them with chemotherapy. This approach is different from standard treatments that typically use either chemotherapy or immunotherapy alone. ^{1 2 3 4 9}

Research Team

Jason Chesney, MD

Principal Investigator

James Graham Brown Cancer Center, University of Louisville

Eligibility Criteria

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Malignant melanoma therapy by chemotherapy and autoimmunity induced by cytokine. [2013]

2. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bio-chemotherapy with dacarbazine plus interleukin-2 in patients with unresectable malignant melanoma. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Multiinstitutional phase II trial of intensive combination chemoimmunotherapy for metastatic melanoma. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

A multicenter phase II clinical trial using dacarbazine and continuous infusion interleukin-2 for metastatic melanoma. Clinical data and immunomonitoring. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Multicenter randomized trial of dacarbazine alone or in combination with two different doses and schedules of interferon alfa-2a in the treatment of advanced melanoma. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Results of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon-{alpha}2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanoma. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The skin: an immunoreactive target organ during interleukin-2 administration? [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Alteration of dacarbazine pharmacokinetics after interleukin-2 administration in melanoma patients. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Dacarbazine and interferon alpha with or without interleukin 2 in metastatic melanoma: a randomized phase III multicentre trial of the Dermatologic Cooperative Oncology Group (DeCOG). [2018]