|
|
| Study Summary No. DM96-172:.......Genitourinary; Bladder......Pagliaro, Lance, M.D.......Genitourinary Medical Oncology |
| Study Summary Title |
| A Phase I Trial Of Intravesical AD-P53 Treatment In Locally Advanced and Metastatic Bladder Cancer | ||||
| Physician | New Patient Referral |
| Name: | Pagliaro, Lance, M.D. | Patients Call: | 800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.) | |
| Dept: | Genitourinary Medical Oncology | Referring MD Call: | 800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.) | |
| Phone: | 713-792-2830 | |||
| Contact us about clinical trials |
| General Information. |
| Disease Group: | Genitourinary Bladder | Sponsor(s): | NCI/Introgen | |
| Phase of Study: | 1 | Return Visit: | ||
| Treatment Agents: | AD-P53 | Home Care: | ||
| Treatment Loc: | ||||
| Estimated Length of Stay in Houston: | ||||
| Description of Study: |
| Enrollment Eligibility |
| Inclusion Criteria: | Patient has histologically confirmed transitional cell carcinoma of the bladder with muscle-invasion or lamina propria invasion (T1-T4)? Patient has unreseectable local regional disease, or distant visceral metastasis which are asymptomatic, or has refused cystectomy (as defined in section 4.3 of the protocol)? Patient has bidimensionally measurable disease? Does patient have expected survival of > 12 wks? Is patient >/= 18 yrs old? Is Zubrod performance status 0,1, or 2? Has informed? consent been obtained Patients with muscle invasion who have failed to respond to CDDP-based chemotherapy or has developed recurrence persistent tumor after chemotherapy? Patient has not received prior gene therapy? Has patient been off radiotherapy >/= 6 weeks? Has patient been off chemotherapy >/= 21 days (>/= 42 days for mitomycin C and nitrosoureas)? Patient has recovered from any toxicity from prior chemotherapies and manifests at most grade 2 toxicity in any organ system? Patient has some control of bladder function (< NCI grade 3 incontinence)? Patient is not lactating and serum pregnancy test is negative if patient is of childbearing potential? Patient agrees to use barrier method of birth control? Patient has negative serology for HIV? Patient does not have active viral, bacterial, or fungal infections requiring treatment? Patient has no serious concurrent illness or psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with protocol? Patient has negative adenoviral culture of urine prior to treatment on-study? Patient is not being concurrently treated with other investigational agents? If patient does not have muscle invasion (T1), patient has concomitant carcinoma in situ (CIS) or has recurrent/persistent tumor following >/= 1 course of intravesical BCG immunotherapy? If patient has received BCG and has only CIS disease, are lesion sufficiently raised and demarcated to be measurable? |
| Exclusion Criteria: |