Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Melanoma
A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
NCT00022568CI-TRIAL-00013011unknownPhase 1ClinicalTrials.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: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant vaccinia-TRICOM vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma * Lesion(s) must be accessible to percutaneous injection * Measurable lesion(s) * At least 1.0 cm * Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed * At least 6 weeks since prior definitive therapy (surgery or radiotherapy) * No untreated or edematous metastatic brain lesions or leptomeningeal disease * No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 * Absolute granulocyte count at least 3,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * Direct bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications) * No hepatic insufficiency * No alcoholic cirrhosis Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min * No renal insufficiency Cardiovascular: * No congestive heart failure * No serious cardiac arrhythmias * No evidence of recent prior myocardial infarction on EKG * No clinical coronary artery disease Pulmonary: * No chronic obstructive pulmonary disease Immunologic: * No prior eczema * HIV negative * No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds) * No clinical or laboratory evidence of an underlying immunosuppressive disorder * No active or chronic infections * No significant allergy or hypersensitivity to eggs Other: * No active seizure disorders * No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free * No evidence of bone marrow toxicity * No other concurrent medical illness that would preclude study * No other contraindications to vaccinia virus administration * No encephalitis * Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior vaccinia immunization required (e.g., smallpox vaccination) * More than 8 weeks since prior immunotherapy and recovered * No prior therapy with live vaccinia virus vector Chemotherapy: * More than 4 weeks since prior chemotherapy and recovered Endocrine therapy: * At least 4 weeks since prior systemic corticosteroids * No concurrent systemic corticosteroids * No concurrent steroids Radiotherapy: * See Disease Characteristics * More than 2 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered Other: * No concurrent immunosuppressive drugs
References
Publications (0)
Data not yet available
No reference posted for this study.