Clinical trial · Interventional
Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Melanoma
Immunotherapy for Malignant Melanoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
NCT00004022CI-TRIAL-00009908completedPhase 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: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery in treating patients who have stage III or stage IV 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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| autologous tumor cell vaccine | Biological | — | UNRESOLVED |
| muromonab-CD3 | Biological | — | UNRESOLVED |
| surgical procedure | Procedure | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven stage III or IV malignant melanoma * Resectable disease * At least 50,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0 or 1 Life expectancy: * At least 6 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least lower limit of normal * No active or recent uncontrolled bleeding Hepatic: * Bilirubin normal * SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: * Creatinine normal Other: * Negative stool guaiac * No impaired immunity * No uncontrolled diabetes * No active uncontrolled infections * No other serious disease * No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * At least 2 weeks since prior therapy and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.