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

• Status: Active, not recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: James Graham Brown Cancer Center; University of Louisville
• Collaborators: James Graham Brown Cancer Center; University of Louisville
• Treatments: Aldesleukin; Dacarbazine; Interleukin-2

Criteria

Inclusion Criteria:

• Patients must fulfill one of the following criteria:

• T4 NO MO - Deep primary melanoma (> 4.0 mm) with or without lymphadenectomy.

• T1-4 N1-3 MO - Primary melanoma with regional lymph node metastases found at lymphadenectomy or sentinel lymph node sampling, but clinically undetectable (occult).

• T1-4 N1-3 MO - Primary melanoma with clinically apparent (overt) regional lymph node metastases confirmed by lymphadenectomy.

• T1-4 N1-3 MO - Recurrence of melanoma at the proximal regional lymph node(s).

• Patients must have undergone a wide excision of the primary and, if >1mm in depth, have completed sentinel lymph node sampling or lymphadenectomy as is standard of practice. Patients must have confirmation of adequate surgical margins around the primary lesion (1 or 2 cm minimum, for primary lesions of 1-2 mm depth; 2 cm for primary lesions equal to or greater than 2 mm depth). When entering this study with recurrent regional lymph node disease, the patient must be enrolled no later than 90 days from the date of lymphadenectomy.

• For subungual melanomas a distal interphalangeal. amputation is required. For patients with regional lymph node recurrence, the same evidence for adequate margins around the primary are required as for patients at initial presentation.

• For safety reasons, patients must be of age between 18 and 85.

• Patients must have ECOG performance status 0-2.

• Patients must have WBC >3,000, platelet count >100,000, and hematocrit >33.

• Patients must have SGOT and bilirubin <2x normal; creatinine <2.3; BUN <33.

• Patients must have no active medical or psychiatric disorders requiring therapy that would prevent completion of the protocol.

• Patients must give written informed consent.

Exclusion Criteria:

• Patients for whom histopathologic examination of the primary or metastatic melanoma is not positive are ineligible.

• Patients who have clinical, radiological, laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease are ineligible.

• Patients with an active second cancer (except in situ cervical cancer, or basal or squamous skin cancer) are ineligible. Exceptions may be discussed with the principal investigator.

• Patients with organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol, are ineligible.

• Patients who have had prior adjuvant chemotherapy, immunotherapy, including preoperative infusion or perfusion therapy are ineligible.

• Patients with recurrent melanoma at regional lymph nodes must not have been previously entered into this study.

• Patients with more than one lymph node group involved are ineligible.

• Women of child bearing age who are not on adequate birth control are ineligible.

• Women who are pregnant or breast feeding are ineligible.