A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
- Conditions
- Non-muscle Invasive Bladder Cancer
- Interventions
- Biological: ALT-801Drug: Gemcitabine
- Registration Number
- NCT01625260
- Lead Sponsor
- Altor BioScience
- Brief Summary
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to undergo a radical cystectomy recommended by the participating urologist as the standard next therapy per urologic guidelines. The purpose of this study is to confirm the safety and tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in treated patients. The anti-tumor responses will also be assessed.
- Detailed Description
Bladder cancer is the fifth most common cancer in the United States with an estimated 71,000 new cases and approximately 14,000 deaths in 2009. Bladder cancer is also the costliest to treat per patient of all cancers, with annual direct medical expenditures in excess of $3.7 billion in the United States. This is largely because approximately 70% of all new cases of bladder cancer present as non-muscle invasive bladder cancer (NMIBC), which tends to recur, requiring repeated interventions and long-term follow-up.
Altor Bioscience Corp. has developed a tumor-targeted IL-2 fusion protein, ALT-801, comprising human recombinant IL-2 genetically linked to a TCR domain capable of binding a tumor associated human p53 peptide presented in the context of HLA-A2.
ALT-801 will be evaluated as to whether it can prevent disease progression and allow for bladder preservation to maintain the quality of life for patients with BCG failure, defined as refractory, relapsing or intolerant, non-muscle invasive bladder cancer who refuse or are not medically fit to undergo a radical cystectomy recommended by the participating urologist as the standard next therapy per urologic guidelines.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 0.06 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine ALT-801 ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2 0.08 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine Gemcitabine ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2 0.06 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine Gemcitabine ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2 0.08 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine ALT-801 ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2
- Primary Outcome Measures
Name Time Method Safety Profile 12 weeks Confirmation of the safety and tolerability (dose limiting toxicity count) of ALT-801 combined with gemcitabine.
Disease Response Rate From start of study treatment to up to 13 weeks The response rate was calculated as the ratio of the number of patients who demonstrated a complete response (by RECIST v1.1) divided by the number of patients evaluable for response. A complete response was defined as having negative bladder biopsy results.
- Secondary Outcome Measures
Name Time Method Overall Survival From start of study treatment to up to 3 years OS was defined as the time from start of study treatment to death resulting from any cause.
Duration of Response From confirmed complete response to up to 3 years Duration of response was defined as the time from the date of first complete response (by RECIST v1.1) to the date of disease progression (by RECIST v1.1) or death (from any cause), whichever occured first. A complete response was defined as having negative bladder biopsy results. Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Progression-free Survival From start of study treatment to up to 3 years The progression-free survival was defined as the time from the start of study treatment to first documentation of objective tumor progression or disease recurrence (by RECIST v1.1). Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Event-free Survival From start of study treatment to up to 3 years The event-free survival was defined as the time from the start of study treatment to first documentation of objective tumor progression (by RECIST v1.1), disease recurrence, bladder resection or irradiation, other anti-bladder cancer therapy, or to death due to any cause, which ever came first. Disease progression by RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Trial Locations
- Locations (5)
UPMC Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
University of California Davis
🇺🇸Sacramento, California, United States
UF Health Center at Orlando Health
🇺🇸Orlando, Florida, United States