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Table 1

Completed trials at CWRU using sequential CT-guided biopsies of solid tumors for Phase I/II drug development

StudyNo. ptsa on trial (requiring biopsy)No. pts having biopsiesNo. of biopsiesLocation of biopsiesPrimary tumorPharmacodynamic end pointSuccess rate for obtaining paired biopsies containing tumor
Phase I trial of tiazofurin and BCNU (Ref. 6) 21 (ns) 10 18 Liver 4 LN 4 Abdo wall 1 Subcut 1 Colorectal 8 Melanoma 1 SCLC 1 Depletion of nicotinamide and ATP with tiazofurin. No correlation was seen.    7 of 103 pts with either normal or necrotic tissue on one of the two biopsies 
Phase I trial of topotecan as 72-h weekly infusion (Ref. 8) 22 (ns) 8 (pretreatment only) Liver 4 LN 3 Pelvic mass 1 Colorectal 8 No correlation between pretreatment topoisomerase levels and response was seen.    6 of 82 fibrotic specimens 
Phase I trial of streptozotocin and BCNU (Ref. 7) 15 (10 requiring biopsy) 10 19 Liver 9 LN 1 Colon 10 Streptozotocin decreased alkyltransferase levels but incompletely.    9 of 10 1 vasovagal reaction 
Phase I trial of O6BG and BCNU (Ref. 3) 53 (38 requiring biopsy) 38 62 Liver 28 Breast 3 LN 2 Lung 1 Abd. mass 2 Cheat wall 1 Spleen 1 Breast 5 Colorectal 22 Lungs 2 Renal 1 Gastric 3 Sinus 1 UNK pr. 2 Pancreas 1 Soft tissue sarcoma 1 Increasing doses of O6-benzylguanine resulted in total depletion of alkyltransferase.   31 of 38 5 necrotic tissue 1 caps hemorrhage 1 pt refused second biopsy 
Phase I trial of temozolomide (Ref. 4) 22 (16 requiring biopsy) 16 31 Liver 15 LN 1 Colorectal 8 Sinus 1 Pancreas 2 Melanoma 1 Small int 1 Breast 2 Unk pr 1 Temozolamide depletion of alkyltransferase was demonstrated but with residual alkyltransferase activity.   15 of 16 1 pt refused second biopsy 
Phase I trial of paclitaxel and concurrent radiation in head and neck cancer (Ref. 5) 24 (ns) 12 (3 each) H + N Cancer 4 H + N Cancer 4 Correlation of paclitaxel dose and mitotic arrest was seen.    4 of 4 
Phase II trial of irinotecan in colon cancer (Ref. 9) 21 (all require biopsy) 21 42 Liver 18 Pelvic mass 2 LN 1 Colon 21 Determination of topoisomerase levels as predictors of response to irinotecan. Results pending.   21 of 21 
Total — 107 192 Liver 78 LN 12 Pelvic/abdo mass 5 H + N 4 Breast 3 Chest/abdo wall 2 s.c. 1 Splenic 1 Lung 1 Colorectal 77 Breast 7 H + N 4 Pancreas 3 Unknown primary 3 Gastric 3 Melanoma 2 Lung 2 Sinus 2 Renal 1 SCLC 1 Small intestinal 1 Soft tissue sarcoma 1    87 of 99    (88%) (excluding the 8 pts who were planned to receive pretreatment biopsy only) 
StudyNo. ptsa on trial (requiring biopsy)No. pts having biopsiesNo. of biopsiesLocation of biopsiesPrimary tumorPharmacodynamic end pointSuccess rate for obtaining paired biopsies containing tumor
Phase I trial of tiazofurin and BCNU (Ref. 6) 21 (ns) 10 18 Liver 4 LN 4 Abdo wall 1 Subcut 1 Colorectal 8 Melanoma 1 SCLC 1 Depletion of nicotinamide and ATP with tiazofurin. No correlation was seen.    7 of 103 pts with either normal or necrotic tissue on one of the two biopsies 
Phase I trial of topotecan as 72-h weekly infusion (Ref. 8) 22 (ns) 8 (pretreatment only) Liver 4 LN 3 Pelvic mass 1 Colorectal 8 No correlation between pretreatment topoisomerase levels and response was seen.    6 of 82 fibrotic specimens 
Phase I trial of streptozotocin and BCNU (Ref. 7) 15 (10 requiring biopsy) 10 19 Liver 9 LN 1 Colon 10 Streptozotocin decreased alkyltransferase levels but incompletely.    9 of 10 1 vasovagal reaction 
Phase I trial of O6BG and BCNU (Ref. 3) 53 (38 requiring biopsy) 38 62 Liver 28 Breast 3 LN 2 Lung 1 Abd. mass 2 Cheat wall 1 Spleen 1 Breast 5 Colorectal 22 Lungs 2 Renal 1 Gastric 3 Sinus 1 UNK pr. 2 Pancreas 1 Soft tissue sarcoma 1 Increasing doses of O6-benzylguanine resulted in total depletion of alkyltransferase.   31 of 38 5 necrotic tissue 1 caps hemorrhage 1 pt refused second biopsy 
Phase I trial of temozolomide (Ref. 4) 22 (16 requiring biopsy) 16 31 Liver 15 LN 1 Colorectal 8 Sinus 1 Pancreas 2 Melanoma 1 Small int 1 Breast 2 Unk pr 1 Temozolamide depletion of alkyltransferase was demonstrated but with residual alkyltransferase activity.   15 of 16 1 pt refused second biopsy 
Phase I trial of paclitaxel and concurrent radiation in head and neck cancer (Ref. 5) 24 (ns) 12 (3 each) H + N Cancer 4 H + N Cancer 4 Correlation of paclitaxel dose and mitotic arrest was seen.    4 of 4 
Phase II trial of irinotecan in colon cancer (Ref. 9) 21 (all require biopsy) 21 42 Liver 18 Pelvic mass 2 LN 1 Colon 21 Determination of topoisomerase levels as predictors of response to irinotecan. Results pending.   21 of 21 
Total — 107 192 Liver 78 LN 12 Pelvic/abdo mass 5 H + N 4 Breast 3 Chest/abdo wall 2 s.c. 1 Splenic 1 Lung 1 Colorectal 77 Breast 7 H + N 4 Pancreas 3 Unknown primary 3 Gastric 3 Melanoma 2 Lung 2 Sinus 2 Renal 1 SCLC 1 Small intestinal 1 Soft tissue sarcoma 1    87 of 99    (88%) (excluding the 8 pts who were planned to receive pretreatment biopsy only) 
a

Pt, patient; ns, not stated in protocol; SCLC, small cell lung cancer.

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