Solid tumors.
Conditions
Interventions
Intervention group: In this phase 1 clinical trial, 20 patients with solid tumors, primarily head and neck and lung cancers, who have not responded to first and second-line treatments, will receive On
Sponsors
Iranian academic center for education culture and research
Iran National Science Foundation
Modiriat Atiyeh Bahman Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 or older Diagnosis of solid tumors, including head and neck, lung, breast cancer, etc., confirmed by histopathology, and the patient has not achieved a complete response to standard treatments such as radiotherapy and chemotherapy. The disease is in advanced stages (Stage 3 or 4). The patient has a healthy liver, kidneys, and brain Neutrophil count = 1,800 cells/mm³Platelet count = 100,000 cells/mm³Hemoglobin level = 8.0 g/dLBilirubin level = 1.5 mg/dLCreatinine level = 1.5 mg/dL Negative pregnancy test Negative HIV test Negative HBV test
Exclusion criteria
Exclusion criteria: Presence of any systemic infection. Having an autoimmune disease or any type of immunodeficiency disorder Systemic treatment with corticosteroids. Allergy to medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (according to CTCAE criteria). Timepoint: Daily (at 1, 2, 4, 6, and 24 hours after injection) during the 5-day virus injection period, Weekly for up to 4 weeks after the last injection, Monthly for up to 6 months after the last injection (if possible, to assess late-onset adverse events). Method of measurement: Daily clinical assessment (physical examination, vital signs monitoring), blood tests (CBC, biochemistry, liver and kidney function tests), symptoms such as fever, pain, fatigue, and other adverse events, medical imaging.;Determination of the maximum tolerated dose (MTD). Timepoint: Monitoring of dose-limiting toxicity (DLT) during the 5-day virus administration and for 2 weeks after the last injection to confirm the maximum tolerated dose. Method of measurement: physical examination, vital signs monitoring, blood tests (CBC, biochemistry, liver and kidney function tests), clinical symptoms such as fever, pain, fatigue, and other adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of viral presence in blood, urine, and other bodily fluids. Timepoint: At baseline (before injection), on days 2, 4, and 6 of injection, and then at weeks 1, 2, and 4 after the last injection. . Method of measurement: The measurement of viral presence in blood, urine, and other bodily fluids will be performed using PCR technique.;Assessment of inflammation-related markers (e.g., CRP, ESR). Timepoint: At baseline (pre-injection), on days 2, 4, and 6 of injection, and subsequently at weeks 1, 2, and 4 after the final injection. Additionally, monthly evaluations will be performed up to 6 months post-final injection, if feasible. Method of measurement: Inflammatory markers, CRP and ESR, will be assessed through blood tests.;Quality of Life (QoL) assessment. Timepoint: Quality of life (QoL) will be assessed at baseline, at weeks 1 and 4 after the last injection, and every 8 weeks up to 6 months. Method of measurement: Quality of Life (QoL) will be evaluated using standardized questionnaires based on patient-reported outcomes at specified time points.;Minimum effective dose. Timepoint: The evaluation of viral replication in the tumor on the final day of injection and assessment of necrosis and apoptosis two days after the last injection. Changes in immune cells will be monitored daily from the first day of injection up to five days, and subsequently on a weekly basis for up to two weeks after the final injection. Method of measurement: Viral replication and spread within the tumor by PCR, tumor cell death by pathological analysis, and the virus-induced anti-tumor immune response through changes in the ratio and count of WBCs. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Kadkhodazadeh Barzoki
Iranian academic center for education culture and research
Outcome results
None listed