Bladder CancerPhase 1NCT00016237
Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
A Phase 1 study testing tucotuzumab celmoleukin in people with Bladder Cancer and Kidney Cancer, run by EMD Serono at 2 sites in United States.
Trial summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Kidney Cancer, Lung Cancer
- What is being tested?
- tucotuzumab celmoleukin
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Dec 2000to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of 1 of the following: Renal cell carcinoma Bladder carcinoma Lung carcinoma Refractory disease or with no anticipated benefit from conventional treatment No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL WBC at least 3,500/mm3 OR Granulocyte count at least 2,000/mm3 Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN Renal: Creatinine less than 2 times ULN Cardiovascular: Normal EKG No prior myocardial infarction No arteriovenous block greater than I, complete hemiblock, hypertrophy, or relevant arrhythmia No uncontrolled hypertension (diastolic at least 100 mmHg) or hypotension (systolic no greater than 90 mmHg) No prior episodes of syncope No prior cardiac disease or significant risk factors for coronary artery disease, unless there is no evidence of myocardial ischemia on exercise thallium scan or other exam (e.g., exercise EKG or dobutamine stress echocardiography) or there is no evidence of significantly impaired left ventricular function on echocardiographic exam Normal thallium scan if patient is at least 65 years old Pulmonary: Normal chest x-ray No pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema Other: No concurrent infection No clinical evidence of immunosuppression No known hypersensitivity to study drug, interleukin-2, Tween-80, or human immunoglobin No other condition that would preclude study No Addison's disease No Crohn's disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study Thyroid-sensitizing hormone no greater than 4.7 mU/L
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior biologic therapy No other concurrent immunotherapy Chemotherapy: At least 30 days since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No concurrent chemotherapy Endocrine therapy: At least 30 days since prior endocrine therapy No concurrent systemic corticosteroid therapy Radiotherapy: No prior radiotherapy to at least 25% of bone marrow At least 30 days since prior radiotherapy At least 3 months since prior radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) No concurrent radiotherapy Surgery: At least 3 weeks since prior major surgery No prior organ transplantation Other: At least 30 days since prior investigational drug No prior therapy that would preclude study No other concurrent investigational drugs No concurrent immunosuppressive therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 combined with a monoclonal antibody may be an effective treatment for kidney, bladder, or lung cancer.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal antibody in treating patients who have kidney, bladder, or lung cancer that has not responded to previous treatment.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of KSA-interleukin-2 in patients with refractory epithelial carcinoma. II. Characterize the pharmacokinetics of this drug in these patients. III. Assess the overall toxicity and safety of this drug in these patients. IV. Determine the rate of objective response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive KSA-interleukin-2 (KSA-IL-2) IV over 1 hour on days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 33% of the patients experience a dose-limiting toxicity. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 6-12 months.
- Conditions
- Bladder Cancer, Kidney Cancer, Lung Cancer
- Being tested
- tucotuzumab celmoleukin
- Keywords
- recurrent non-small cell lung cancer, squamous cell lung cancer, stage IV renal cell cancer, recurrent renal cell cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent bladder cancer, stage IV bladder cancer, stage IV non-small cell lung cancer, transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder
- Medical subject headings
- Urinary Bladder Neoplasms, Kidney Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tucotuzumab celmoleukinBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2004 (estimated)
- Study startDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert J. Motzer, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016237
- Sponsor's protocol ID
- CDR0000068612
- Other IDs
- MSKCC-00141, EMD-EMR-62-206-003, NCI-G01-1944
- Status last verified
- Jun 2002
- First submitted
- 6 May 2001
- Last updated
- 23 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer
- ClinicalTrials.gov ID
- NCT00016237
- Acronym / sponsor ID
- CDR0000068612
- Conditions
- Bladder Cancer, Kidney Cancer, Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, squamous cell lung cancer, stage IV renal cell cancer, recurrent renal cell cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent bladder cancer, stage IV bladder cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center
- Study start
- Dec 2000
- First posted
- 7 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 combined with a monoclonal antibody may be an effective treatment for kidney, bladder, or lung cancer.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal antibody in treating patients who have kidney, bladder, or lung cancer that has not responded to previous treatment.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of KSA-interleukin-2 in patients with refractory epithelial carcinoma. II. Characterize the pharmacokinetics of this drug in these patients. III. Assess the overall toxicity and safety of this drug in these patients. IV. Determine the rate of objective response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive KSA-interleukin-2 (KSA-IL-2) IV over 1 hour on days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 33% of the patients experience a dose-limiting toxicity. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 6-12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tucotuzumab celmoleukin | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J. Motzer, MD study chair
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tucotuzumab celmoleukin in people with Bladder Cancer and Kidney Cancer, run by EMD Serono at 2 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: finished, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 23 Oct 2013.