MelanomaPhase 2NCT01355562
Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
A Phase 2 study testing Interleukin-2 (IL-2) in people with Melanoma and Metastatic Kidney Cancer, run by Loma Linda University at 2 sites in United States.
Trial summary
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Metastatic Kidney Cancer
- What is being tested?
- Interleukin-2 (IL-2)
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Feb 2012
- Phase
- Phase 2
- 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
Who may be able to join
- Patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma Patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer.
- Patients must have measurable disease on physical exam or radiologic studies.
- ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
- White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl.
- Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
- Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
- Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
Who cannot join
- Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate).
- Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy.
- Prior history of psychiatric disorder, which could be exacerbated by interleukin-2.
- Lactation or pregnancy.
- Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
- Current brain metastasis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Highland Springs Medical Plaza
Beaumont, California, 92223
Loma Linda University Cancer Center
Loma Linda, California, 92354
About this study
Official title: Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.
Read the detailed description
The current study will test single agent IL-2 given daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting in stage IV melanoma and kidney cancer to attempt to determine the response rate, how long the responses last, and median survival of this regimen in these two diseases. Responding patients and those with absence of disease progression may receive additional cycles of therapy every 3 weeks.
- Conditions
- Melanoma, Metastatic Kidney Cancer
- Being tested
- Interleukin-2 (IL-2)
- Medical subject headings
- Melanoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2 (IL-2)Drug
Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 9 weeks
Secondary outcomes (1)
how long the tumor shrinkage lasts
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Primary Investigator is no longer employed at LLU as of 02/29/12.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Shing Chen, Loma Linda University
- Investigators
- Walter Quan, Jr., M.D., Principal investigator, Loma Linda University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355562
- Sponsor's protocol ID
- 5110062
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2011
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
- ClinicalTrials.gov ID
- NCT01355562
- Acronym / sponsor ID
- 5110062
- Conditions
- Melanoma, Metastatic Kidney Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Primary Investigator is no longer employed at LLU as of 02/29/12.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 May 2011 (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.
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.
Detailed description
The current study will test single agent IL-2 given daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting in stage IV melanoma and kidney cancer to attempt to determine the response rate, how long the responses last, and median survival of this regimen in these two diseases. Responding patients and those with absence of disease progression may receive additional cycles of therapy every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma Patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer.
- Patients must have measurable disease on physical exam or radiologic studies.
- ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
- White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl.
- Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
Key exclusion criteria (6 listed)
- Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate).
- Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy.
- Prior history of psychiatric disorder, which could be exacerbated by interleukin-2.
- Lactation or pregnancy.
- Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
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 |
|---|---|---|
| Interleukin-2 (IL-2)Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting | Drug | – |
Primary outcome
Response rate
Time frame: 9 weeks
1 secondary outcome
how long the tumor shrinkage lasts
Time frame: 9 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Related InfoLink provided by the sponsor.
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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.
Walter Quan, Jr., M.D. principal investigator
Loma Linda University 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 2 study testing Interleukin-2 (IL-2) in people with Melanoma and Metastatic Kidney Cancer, run by Loma Linda University 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?
The sponsor lists 7 inclusion and 6 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 30 Apr 2020. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Response rate (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
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 30 Apr 2020.