Table 6.1.
Patients cohorts and treatment profile
| Cohorts | No. of patientsa | Diagnosisb | Prior treatmentsc | Dose (vp) | Biopsy time | Adverse eventsd |
|---|---|---|---|---|---|---|
| 1 | 1 (1) | BrCa (1) | S, C, Ca, N, H, G | 2 × 1010 | +24 h | 2 |
| 2 | 1 (1) | CoCa (1) | S, F, I | 2 × 1011 | +24 h | 1 |
| 3 | 3 (3) | SCCHN (1), Mel (1), LCL (1) | S, RT, T, P, C, V, D, Fl, Cl | 2 × 1012 | +24 h | 0/1/1 |
| 4 | 3 (3) | BrCa (1), AdrCa (1), Hep (1) | S, A, C, T, Ta, N, P, RT, E | 2 × 1012 | +48 h | 0/1/0 |
| 5 | 4 (3) | BrCa (1), Mel (1), Mel (1) | S, Ta, RT, I, D | 2 × 1012 | +96 h | 0/2/2 |
| 6 | 1 (1) | BrCa (1) | S, A, T, Ta | 2 × 1012, divided dose | +48 h | 0 |
| 7 | 7 (5) | TCC (1), Mel (1), CoCa (1), SCCHN (2) | S, M, V, A, P, T, G, RT, F, I | 2 × 1012 | Day 30 | 2/0/0/2/2 |
| 8 | 8 (5) | Mel (3), SCCHN (2) | S, RT, IF, IT, P, T, F | 2 × 1012, twice weekly × 3 | Day 30 | 2/2/2/1/1/e |
Number of patients enrolled per cohort is listed. The number of patients completing at least one round of treatment is indicated in parentheses
Diagnosis: BrCa breast carcinoma, CoCa colon carcinoma, SCCHN squamous cell carcinoma of the head and neck, Mel melanoma, LCL large cell lymphoma, AdrCa Adrenal carcinoma, Hep hepatoma, TCC transitional cell carcinoma
Prior treatments: S Surgery, A adriamycin, C cyclophosphamide, Ca capecitabine, Cl chlorambucil, D dacarbazine, E etoposide, F 5-fluorouracil, Fl fludarabine, G gemcitabine, H herceptin, I irinotecan, IF IFN-α, IT immunotherapy, M methotrexate, N navelbine, P platinum, RT radiotherapy, T taxane, Ta tamoxifen, V vincistine
Adverse effects possibly due to Ad.MDA-7 (INGN 241) administration are indicated
One patient from cohort 8 experienced a grade 3 SAE and withdrew from the study (Adapted by permission from Cunningham et al. [11], Copyright 2005)