Table 1. Patient details: possible/probable CC-5013-related adverse effects.
| Patient no. | Age (years)/sex | Disease | Stagea | Site | Previous treatment | Responseb | Completed/withdrew | Days on study/maximum dose (mg) | Samples for in vitro analysis |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 45/F | Malignant melanoma | IVabc | Right ileoinguinal area | Cancervax trial | PD | Completed | 28/50 | No |
| 2 | 28/F | Malignant melanoma | IVabc | Right thigh | Dacarbazine (three cycles); peptides (melanA, gp100, tyrosinase) and IL-2 | SD; partial response of liver | Completed | 28/50 | No |
| 3 | 58/M | Malignant melanoma | IVabc | Lower abdomen | Dacarbazine; radiotherapy | PD | Progressed | 14/10 | No |
| 4 | 44/F | Malignant melanoma | IVa | Abdomen | Adjuvant interferon | SD; minor response of abdominal nodes | Completed | 28/50 | No |
| 5 | 16/M | Malignant melanoma | IVac | Right temporal region | Adjuvant interferon | PD; minor response of small cutaneous lesion | Completed | 28/50 | No |
| 6 | 56/F | Malignant melanoma | IVabc | Vulva | Chemotherapy; bilateral groin radiotherapy | SD | Completed | 28/50 | No |
| 7 | 31/M | Malignant melanoma | IVabc | Left upper chest | Debulking surgery; peptide (triple) and IL-2; dacarbazine; vindesine X3 | SD; minor response of subcutaneous lesion | Completed | 28/50 | Yes |
| 8 | 80/M | Malignant melanoma | IVab | Right side of neck | Treosulphan (six cycles) | PD | Completed | 28/50 | Yes |
| 9 | 48/M | Malignant melanoma | IVa | Left foot | BCG (two doses) | SD; minor response of cutaneous nodules | Completed | 28/50 | Yes |
| 10 | 56/F | Malignant melanoma | IVac | Breast | Vinflunine; radiotherapy | PD | Completed | 28/50 | No |
| 11 | 23/M | Malignant melanoma | IVabc | Abdomen | Adjuvant interferon; radical radiotherapy | PD | Progressed | 24/50 | Yes |
| 12 | 51/M | Malignant melanoma | IVac | Right thigh | Carboplatin, dacarbazine, vincristine, vinblastine & vindesine | SD | Completed | 28/50 | Yes |
| 13 | 64/M | Malignant melanoma | IVabc | Right chest wall, right lower eyelid, lips | Multiple surgery only | PR, CT & complete subcutaneous response | Completed | 28/50 | Yes |
| 14 | 52/M | Adenocarcinoma of the Pancreas | IV | Pancreas & portal vein | M. vaccae; retinoic acid & gemcitabine | PD; minor response serum CA19.9 | Completed | 28/50 | Yes |
| 15 | 47/M | Carcinoid | IV | Multiple carcinoid tumours | Radiotherapy; 5-fluorouracil & folinic acid; interferon; etoposide & cisplatin; thalidomide | N/E entered inappropriately | Withdrew | 14/10 | No |
| 16 | 34/M | Adenocarcinoma of the Pancreas | IV | Head of pancreas | Gemcitabine & tomudex | PD | Completed | 28/50 | Yes (ELISA only) |
| 17 | 55/F | Renal cell carcinoma | IV | Left kidney | Interferon; bryostatin; thalidomide; radiotherapy | N/E withdrew due to adverse effects | Withdrew | 16/10 | No |
| 18 | 65/F | Ductal carcinoma of the breast | II | Breast | Mitozantrone, methotrexate & mitomycin; cyclophosphomide methotrexate & 5-fluorouracil; megace; 5-fluorouracil, epirubicin & cyclophosphomide; herceptin; tamoxifen; radiotherapy | N/E withdrew due to generalised weakness | Withdrew | 14/10 | No |
| 19 | 66/M | Squamous cell carcinoma of the lung | IV | Right lung | Mitomycin, winblastine sulphate & cisplatin; radiotherapy | PD | Progressed | 26/25 | No |
| 20 | 66/F | Adenocarcinoma of the lung | III | Left lung | Radiotherapy; mitomycin, vinblastine & cisplatin | PD | Completed | 28/50 | Yes |
a
Staging: a, skin, subcutaneous tissue, lymph node metastases; b, lung and gastrointestinal metastases; c, other sites including liver, bone and brain metastases.
b
Response: PR=partial response; SD=static disease; PD=progressive disease; N/E=nonevaluable.