TerminatedPhase 1/2

A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer

Stopped: The study was terminated early due to low enrollment.

United States12 participantsStarted 2012-03-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

ENTRY CRITERIA: DISEASE CHARATERISTICS: * Histologically confirmed high-risk (high grade Ta, T1 or carcinoma in situ, tumor \>4 cm or multi-focal) transitional cell carcinoma s/p TURBT with no remaining resectable disease within 4 weeks of study entry * Intolerant of treatment with BCG or failure (refractory or relapsing) of at least one prior treatment with BCG * Refuse or intolerant of a radical cystectomy * No Evidence of regional and/or distant metastasis PRIOR/CONCURRENT THERAPY: * No concurrent radiotherapy, other chemotherapy, or other immunotherapy * No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation * Must have recovered from side effects of prior treatments * No concurrent use of other investigational agents PATIENT CHARACTERISTICS: Age • ≥ 18 years Performance Status • ECOG 0, 1, or 2 Bone Marrow Reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL * Platelets ≥ 100,000/uL * Hemoglobin ≥ 8 g/dL Renal Function • Glomerular Filtration Rate (GFR) ≥ 50mL/min Hepatic Function * Total bilirubin ≤ 2.0 X ULN * AST, ALT, ALP ≤ 3.0 X ULN Cardiovascular * No congestive heart failure \< 6 months * No severe/unstable angina pectoris \< 6 months * No myocardial infarction \< 6 months * No history of ventricular arrhythmias * No NYHA Class \> II CHF * No uncontrollable supraventricular arrhythmias * No history of a ventricular arrhythmia * No other clinical signs of severe cardiac dysfunction * No…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Profile

Timeframe: 12 weeks

Disease Response Rate

Timeframe: From start of study treatment to up to 13 weeks

Trial details

NCT IDNCT01625260

SponsorAltor BioScience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-08

Results submitted2024-04-18

View on ClinicalTrials.gov More Non-muscle Invasive Bladder Cancer trials