Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
Conditions
Non-muscle Invasive Bladder Cancer (NMIBC)
Conditions: official terms
Urinary Bladder Neoplasms
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ABI-009
Type: Drug
Overall Status
Recruiting
Summary
Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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
Locations
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Contact: Danny Lascano - dl2178@cumc.columbia.edu
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Pamela Steele, RN BSN CCRC - 615-343-2120 - pamela.steele@vanderbilt.edu
Start Date
April 2014
Sponsors
Aadi, LLC
Source
Aadi, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page