Clinical trial · Interventional
Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa
The Florida Melanoma Trial: A Phase I/II Trial of Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa in the Treatment of Advanced Stage III Melanoma: Study Site & Coordinating Center
NCT00005615CI-TRIAL-00008140completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining interferon alfa plus radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa plus radiation therapy in treating patients who have stage III or recurrent melanoma that has been removed by surgery.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon alfa | Biological | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interferon Alfa Plus Radiation
- description
- Combined Therapy: interferon alfa plus radiation therapy. Patients receive interferon alfa IV over 20 minutes daily for 5 consecutive days a week for 4 weeks. Patients then receive radiotherapy on days 2 and 4 and interferon alfa subcutaneously (SQ) on days 1, 3, and 5 for 2.5 weeks. Interferon alfa SQ continues 3 times a week for 10 months in the absence of disease progression or unacceptable toxicity. Patients are followed every month for 3 months, then every 3 months for 2 years, then every six months until year 5, and then annually thereafter.
- interventionNames
- Biological: Interferon alfa
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Study Duration: 7 years
- description
- Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven primary melanoma with extensive regional node metastases (T1-4, N1, M0) OR Primary melanoma with clinically apparent metastases confirmed by lymphadenectomy (T1-4, N1-2, M0) OR Clinically detected relapse of melanoma in regional node basin, confirmed by lymphadenectomy after prior management of primary site (T1-4, N1-2, M0) OR Recurrence of melanoma in a nodal basin previously resected OR Nodal metastatic melanoma arising from unknown primary, confirmed by lymphadenectomy (Tx, N1-2, M0) Adenopathy from neck, axilla, or groin basins must meet one of the following criteria: At least 4 positive nodes containing tumor Nodal metastases at least 3 cm in size Gross extracapsular extension of tumor Recurrence after prior lymphadenectomy Completely resected disease No distant metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 125,000/mm3 Hematocrit at least 33% Hepatic: AST, LDH, alkaline phosphatase and bilirubin no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.8 mg/dL BUN no greater than 33 mg/dL Cardiovascular: No congestive heart failure (New York Heart Association class III or IV heart disease) Neurologic: No prior CNS demyelinating or inflammatory disease No prior hereditary or acquired peripheral neuropathy No organic brain syndrome, significant impairment of cognitive function, or psychiatric disorder that would preclude study Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 18 months after study No hypersensitivity to interferon alfa or any component of the injection No history of diabetes mellitus prone to ketoacidosis No uncontrolled thyroid abnormalities No clinically significant retinal abnormalities No other significant medical or surgical condition that would preclude study No prior invasive melanoma No other prior or concurrent malignancies within the past 5 years except any in situ cancer, atypical melanocytic hyperplasia, or basal or squamous skin cancer No autoimmune disorders or immunosuppressive conditions PRIOR CONCURRENT THERAPY: Biologic therapy: Prior vaccine therapy allowed No prior immunotherapy, interferon, interleukins, levamisole, or other biologic response modifiers Chemotherapy: No prior chemotherapy, including infusion or perfusion therapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: No prior radiotherapy to the proposed site(s) of study Surgery: See Disease Characteristics Other: No other medication or treatment regimen that would preclude study No concurrent immunosuppressive therapy
References
Publications (0)
Data not yet available
No reference posted for this study.