Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
NCT00030693CI-TRIAL-00009099terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| recombinant fowlpox-B7.1 vaccine | Biological | — | UNRESOLVED |
| recombinant fowlpox-TRICOM vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (recombinant fowlpox-B7.1 vaccine)
- description
- Patients receive rF-B7.1 vaccine intratumorally on day 1.
- interventionNames
- Biological: recombinant fowlpox-B7.1 vaccine
- Other: laboratory biomarker analysis
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (recombinant fowlpox-TRICOM vaccine)
- description
- Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
- interventionNames
- Biological: recombinant fowlpox-TRICOM vaccine
- Other: laboratory biomarker analysis
- Procedure: quality-of-life assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic unresectable solid tumors * Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections * No standard therapy available * At least 1 unidimensionally measurable lesion * At least 20 mm for visceral lesions * At least 10 mm for cutaneous, subcutaneous, and nodal lesions * No untreated or edematous metastatic brain lesions * At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI * No ascites or pleural effusions * No leptomeningeal disease * Performance status - ECOG 0-1 * More than 3 months * Absolute granulocyte count at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * No bleeding diathesis * Bilirubin no greater than 1.5 mg/dL\* * SGOT/SGPT no greater than 2 times upper limit of normal (ULN)\* * Alkaline phosphatase no greater than 2 times ULN\* * No elevated PT or PTT * No cirrhosis * No active hepatitis * No hepatic insufficiency * Creatinine no greater than 2.0 mg/dL * No renal insufficiency * No chronic obstructive pulmonary disorder * No active autoimmune disorders * No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis) * No significant allergy or hypersensitivity to eggs * No active seizure disorder * No active or chronic infections * No other significant medical disease that would preclude study participation * No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * More than 8 weeks since prior immunotherapy and recovered * More than 4 weeks since prior chemotherapy and recovered * At least 4 weeks since prior systemic corticosteroids * No concurrent corticosteroids * More than 2 weeks since prior radiotherapy and recovered * No evidence of bone marrow toxicity from prior radiotherapy * More than 4 weeks since prior surgery and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.