Clinical trial · Interventional
Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients
Adjuvant Interleukin2 (Proleukin)and 5-(3,3 Dimethyl-1-Triazeno) Imidazole-4-Carboxamide (DTIC) in Resected High-Risk Primary and Regionally Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proleukin and Dacarbazine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proleukin/DTIC Arm
- description
- Adjucant proleukin and DTIC
- interventionNames
- Drug: Proleukin and Dacarbazine
Primary outcomes (1)
- measure
- Relapse-free survival
- timeFrame
- The study duration is projected to be approximately 9 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available