Clinical trial · Interventional
Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs. Biochemotherapy Using Cisplatin + Vinblastine + DTIC + Interferon Plus IL-2
- 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)
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Therapy | Procedure | — | UNRESOLVED |
| Aldesleukin (IL-2) | Biological | Aldesleukin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Recombinant Interferon Alfa (IFN-A) | Biological | — | UNRESOLVED |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- IFN-A Therapy Schedule A
- description
- Schedule A: IV Interferon alfa-2b (IFN-A) induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks.
- interventionNames
- Biological: Recombinant Interferon Alfa (IFN-A)
- type
- EXPERIMENTAL
- label
- IFN-A Therapy Schedule B
- description
- Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks.
- interventionNames
- Biological: Recombinant Interferon Alfa (IFN-A)
- type
- EXPERIMENTAL
- label
- Adjuvant Biochemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically diagnosed malignant melanoma with regional lymph node metastases * Undergone complete lymph node dissection and free of any residual tumor * No greater than 90 days from diagnosis of regional lymph nodes metastases * No distant or resected in-transit metastases PATIENT CHARACTERISTICS: Age: * 10 to 66 * 66 to 70 if in excellent physical condition Performance status: * 0-2 Life expectancy: * At least 12 months Hematopoietic: * Hemoglobin greater than 10 g/dL * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.2 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL Other: * No serious intercurrent illness that would compromise tolerance of therapy and long term survival * Must be able to participate in follow up for minimum of 5 years * No second malignancy except: * In situ cervical cancer * Basal or squamous skin cancer * Must be able to physically and emotionally tolerate biochemotherapy * No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy with interferon or IL-2 * No concurrent immunomodulators Chemotherapy: * No prior chemotherapy Endocrine therapy: * No concurrent steroids Radiotherapy: * Prior adjuvant local radiotherapy allowed for head and neck Surgery: * No greater than 8 weeks after definitive surgery for lymph node metastases Other: * No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase inhibitors
References
Publications (1)
- RESULTKim KB, Legha SS, Gonzalez R, Anderson CM, Johnson MM, Liu P, Papadopoulos NE, Eton O, Plager C, Buzaid AC, Prieto VG, Hwu WJ, Frost AM, Alvarado G, Hwu P, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, Benjamin RS, Bedikian AY. A randomized phase III trial of biochemotherapy versus interferon-alpha-2b for adjuvant therapy in patients at high risk for melanoma recurrence. Melanoma Res. 2009 Feb;19(1):42-9. doi: 10.1097/CMR.0b013e328314b84a. PMID 19430405