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Non-muscle Invasive Bladder CancerPhase 1/2NCT01625260

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

A Phase 1/2 study testing ALT-801 and Gemcitabine in people with Non-muscle Invasive Bladder Cancer, run by Altor BioScience at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle Invasive Bladder Cancer
What is being tested?
ALT-801 and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
5 sitesUnited States
Study dates
30 Mar 2012to 8 Mar 2018
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  • Normal Transthoracic Echocardiogram (TTE) is required for patients who have history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or have history of having received adriamycin or doxorubicin
  • No patients with a left ventricular ejection fraction (LVEF) of less than 50%

Pulmonary

  • Normal clinical assessment of pulmonary function

Other

  • Negative serum pregnancy test if female and of childbearing potential
  • Women who are not pregnant or nursing
  • Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
  • No known autoimmune disease other than corrected hypothyroidism
  • No known prior organ allograft or allogeneic transplantation
  • Not HIV positive
  • No active systemic infection requiring parenteral antibiotic therapy
  • No ongoing systemic steroid therapy required
  • No history or evidence of uncontrollable CNS disease
  • No psychiatric illness/social situation
  • No other illness that in the opinion of the investigator would exclude the subject from participating in the study
  • Must provide informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • UF Health Center at Orlando Health

    Orlando, Florida, 32806

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of California Davis

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: A Phase Ib/II Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-muscle Invasive Bladder Cancer

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.

Read the 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.

Being tested
ALT-801, Gemcitabine
Keywords
cancer, immunotherapy, targeted, non-muscle invasive, interleukin-2, antitumor, TCR, T-cell receptor, p53, p53 gene, p53 tumor supressor protein, urothelial cancer, bladder cancer, HLA-A2 positive, HLA-A*0201/p53 aa264-272, HLA complex, refractory, relapsed, BCG, multi-focal
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Neoplasms, Urinary Bladder Neoplasms, Recurrence, Carcinoma in Situ, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALT-801Biological

    Also called c264scTCR-IL2

    Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.

  • GemcitabineDrug

    Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.

Study groups in NCT01625260
Study groupRoleWhat they receive
0.06 mg/kg ALT-801 with 1000 mg/m^2 GemcitabineExperimentalALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m^2
Receives: Biological: ALT-801; Drug: Gemcitabine
0.08 mg/kg ALT-801 with 1000 mg/m^2 GemcitabineExperimentalALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m^2
Receives: Biological: ALT-801; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Profile

    Confirmation of the safety and tolerability (dose limiting toxicity count) of ALT-801 combined with gemcitabine.

    Measured: 12 weeks

  2. Disease Response Rate

    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.

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

Secondary outcomes (4)

  1. Duration of Response

    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.

    Measured: From confirmed complete response to up to 3 years

  2. Progression-free Survival

    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.

    Measured: From start of study treatment to up to 3 years

  3. Event-free Survival

    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.

    Measured: From start of study treatment to up to 3 years

  4. Overall Survival

    OS was defined as the time from start of study treatment to death resulting from any cause.

    Measured: From start of study treatment to up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2012 (estimated)
  2. Study start30 Mar 2012
  3. Primary completion8 Mar 2018
  4. Study completion8 Mar 2018

Why it stopped: The study was terminated early due to low enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625260
Sponsor's protocol ID
CA-ALT-801-01-12
Status last verified
Jul 2024
First submitted
19 Jun 2012
Last updated
19 Jul 2024
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALT-801 and Gemcitabine in people with Non-muscle Invasive Bladder Cancer, run by Altor BioScience at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Profile (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01625260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.

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