Clinical Trial VICCURO1382
A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles (nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer
- Protocol No. VICCURO1382
- Open Date: 02/10/2014
- Staging: Phase I/II
- Age Group: Adults
- Scope: National
- Objective: In phase 1, to determine the safety, toxicity, and preliminary efficacy profiles of intravesically administered nab-rapamycin at the maximum deliverable dose (MDD). In phase 2, to evaluate the utility (potential for clinical efficacy) and safety of nabrapamycin in the treatment of BCG refractory or recurrent nonmuscle invasive transitional cell carcinoma (TCC) of the bladder as measured by complete response rate (defined as negative bladder biopsy at 6 weeks post-treatment).
- Disease Sites: Bladder
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Nab-rapamycin
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT02009332
- Secondary Protocol No: Not Specified
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive recurrent bladder cancer refractory or recurrent to standard intravesical therapy. Patients must exhibit disease recurrence after receiving adequate intravesical BCG (at least 6 weeks induction plus 3 additional doses of either induction or maintenance). Patients with a history of other intravesical agents in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).
1. For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
2. For phase 2, individuals with Ta disease only must have documentation of high-grade histology
2. Age >18 and must be able to read, understand, and sign informed consent
3. Performance Status: ECOG 0, 1, and 2 (See Appendix III)
4. Hematologic inclusion within 2 weeks of start of treatment
1. Absolute neutrophil count >1,500/mm3
2. Hemoglobin >9.0 g/dl
3. Platelet count >100,000/mm3
5. Hepatic inclusion within 2 weeks of entry
1. Total bilirubin must be within normal limits.
2. Adequate renal function with serum creatinine ≤2.5 mg/dL
3. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN for the institution, alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
6. Women of childbearing potential must have a negative pregnancy test.
7. All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.
1. Any other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excluded
2. Concurrent treatment with any chemotherapeutic agent
3. Women who are pregnant or lactating
4. History of vesicoureteral reflux or an indwelling urinary stent
5. Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
6. History of radiation to the pelvis
7. History of interstitial lung disease and/or pneumonitis
8. Evidence of metastatic disease