Metastatic Renal Cell CarcinomaPhase 4NCT00414765

Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

A Phase 4 study testing Aldesleukin in people with Metastatic Renal Cell Carcinoma and Metastatic Melanoma, run by Novartis Pharmaceuticals at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Renal Cell Carcinoma, Metastatic Melanoma
What is being tested?: Aldesleukin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 4 sitesUnited States
Study dates: 3 Sep 2008to 28 Mar 2010
Phase: Phase 4
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

Who may be able to join

Performance Status Eastern Cooperative Oncology Group: 0 or 1.
Adequate organ function.

Who cannot join

Pregnancy or lactation.
Prior treatment with any form of IL-2.
Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Colorado Cancer Center
Aurora, Colorado, 80045
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC/Kenneth Norris Comprehensive Cancer Center
Los Angeles, California, 90033
James Graham Brown Cancer Center
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies

This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.

Conditions: Metastatic Renal Cell Carcinoma, Metastatic Melanoma
Being tested: Aldesleukin
Keywords: Metastatic Renal Cell Carcinoma, Metastatic Melanoma, Aldesleukin, IL-2
Medical subject headings: Carcinoma, Renal Cell, Melanoma

What participants receive

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

AldesleukinDrug
Also called Proleukin®, PRL002

Study groups in NCT00414765
Study group	Role	What they receive
Aldesleukin	Experimental	All participants were treated with aldesleukin 600,000 international units per kilogram [IU/kg] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. Receives: Drug: Aldesleukin

What is being measured

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

Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy
Measured: From Cycle 1, Day 1 to Cycle 2, Day 15

Timeline

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

3 Sep 200828 Mar 2010

First posted22 Dec 2006 (estimated)
Study start3 Sep 2008
Primary completion28 Mar 2010
Study completion28 Mar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00414765
Sponsor's protocol ID: CPRL002A2201
Status last verified: Jun 2021
First submitted: 21 Dec 2006
Last updated: 8 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
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All Metastatic Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies
ClinicalTrials.gov ID: NCT00414765
Acronym / sponsor ID: CPRL002A2201
Conditions: Metastatic Renal Cell Carcinoma, Metastatic Melanoma
Keywords: Metastatic Renal Cell Carcinoma, Metastatic Melanoma, Aldesleukin, IL-2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 3 Sep 2008 (actual)
Primary completion: 28 Mar 2010 (actual)
Study completion: 28 Mar 2010 (actual)
First posted: 22 Dec 2006 (estimated)
Results: Posted 8 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aldesleukin	Experimental	Drug: AldesleukinAll participants were treated with aldesleukin 600,000 international units per kilogram [IU/kg] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Performance Status Eastern Cooperative Oncology Group: 0 or 1.
Adequate organ function.

Key exclusion criteria (3 listed)

Pregnancy or lactation.
Prior treatment with any form of IL-2.
Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply

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
AldesleukinAlso: Proleukin®, PRL002	Drug	Aldesleukin

Primary outcome

Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy
Time frame: From Cycle 1, Day 1 to Cycle 2, Day 15

Results and safety

Results posted to the registry on 8 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mRCC Group	7	1
Metastatic Melanoma Group	19	8

Primary outcome: Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy

Time frame: From Cycle 1, Day 1 to Cycle 2, Day 15. Mean (Standard Deviation). Unit: hour times picograms per mL(h × pg/mL)

Measure	mRCC Group n = 2	Metastatic Melanoma Group n = 11
Participants With Presence of Anti-IL-2 antibodies (Anti-IL-2 Ab) Titer	60359.9 (37406.04)	173127.7 (223655.01)
Participants With Absence of Anti-IL-2 Ab Titer	–	-22171.6 (14798.46)

Population analysed: The Pharmacokinetic Analysis (PK) set consisted of all participants in the safety set who completed two cycles of aldesleukin therapy and had evaluable post-baseline blood samples on Cycle 1, Day 1 and Cycle 2, Day 15. The Safety set consists of all participants who received at least one dose of aldesleukin and had at least one post-baseline safety assessment.

Adverse events

Time frame: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 47 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mRCC	3 of 7 (42.9%)	0 of 7 (0%)	0 of 7
Metastatic Melanoma	4 of 19 (21.1%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Renal Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma

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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aldesleukin in people with Metastatic Renal Cell Carcinoma and Metastatic Melanoma, run by Novartis Pharmaceuticals at 4 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 8 Jun 2021). 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?

Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy (time frame: From Cycle 1, Day 1 to Cycle 2, Day 15). 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 NCT00414765.

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 8 Jun 2021.