Kidney CancerPhase 3NCT00003126
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
A Phase 3 study testing Interleukin-2 in people with Kidney Cancer, run by Loyola University at 15 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Interleukin-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 1997to Aug 2002
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.
- Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing.
- No history or evidence of cardiac disease on ECG
- No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment.
- No prior history of invasive malignancy in the past 5 years
- Human immunodeficiency virus (HIV) negative
- Female patients must not be pregnant or planning to become pregnant
Who cannot join
- Age younger than 16
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Loyola University Medical Center
Maywood, Illinois, 60153
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Summit Medical Center
Oakland, California, 94609
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
Our Lady of Mercy Medical Center
The Bronx, New York, 10466
About this study
Official title: A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
Read the detailed description
The primary objective of this prospective, randomized, controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.
Patients are stratified according to their disease classification and randomized to one course of IL-2 [600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28 doses)] or observation.
- Conditions
- Kidney Cancer
- Being tested
- Interleukin-2
- Keywords
- renal cell cancer, renal cell carcinoma, interleukin-2
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2Drug
Also called IL-2, Aldesleukin
High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
| Study group | Role | What they receive |
|---|---|---|
| Interleukin-2 (IL-2) | Experimental | Patients randomized to this arm will receive one course of IL-2 [600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)]. Receives: Drug: Interleukin-2 |
| Observation | No intervention | Patients randomized to this arm will receive their normal medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up.
Measured: 60 months
Secondary outcomes (1)
Overall survival
Overall survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death. Living patients will be censored at the date of last follow-up.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2003 (estimated)
- Study startJun 1997
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Kidney 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- Chiron Corporation
- Responsible party
- Sponsor
- Investigators
- Joseph I. Clark, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003126
- Sponsor's protocol ID
- 852006
- Status last verified
- Jan 2017
- First submitted
- 1 Nov 1999
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data
Publications
Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5.
PubMed 12568441Skinner DG, Colvin RB, Vermillion CD, Pfister RC, Leadbetter WF. Diagnosis and management of renal cell carcinoma. A clinical and pathologic study of 309 cases. Cancer. 1971 Nov;28(5):1165-77. doi: 10.1002/1097-0142(1971)28:53.0.co;2-g. No abstract available.
PubMed 5125665Robson CJ, Churchill BM, Anderson W. The Results of Radical Nephrectomy for Renal Cell Carcinoma. J Urol. 2017 Feb;197(2S):S111-S113. doi: 10.1016/j.juro.2016.10.095. Epub 2016 Dec 21. No abstract available.
PubMed 28012766Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. doi: 10.1200/JCO.1999.17.8.2530.
PubMed 10561319Messing EM, Manola J, Wilding G, Propert K, Fleischmann J, Crawford ED, Pontes JE, Hahn R, Trump D; Eastern Cooperative Oncology Group/Intergroup trial. Phase III study of interferon alfa-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern Cooperative Oncology Group/Intergroup trial. J Clin Oncol. 2003 Apr 1;21(7):1214-22. doi: 10.1200/JCO.2003.02.005.
PubMed 12663707Poster DS, Bruno S, Penta JS, Pinna K, Vilk P, Macdonald JS. Current status of chemotherapy, hormonal therapy, and immunotherapy in the treatment of renal cell carcinoma. Am J Clin Oncol. 1982 Feb;5(1):53-60.
PubMed 7081138Finney R. The value of radiotherapy in the treatment of hypernephroma--a clinical trial. Br J Urol. 1973 Jun;45(3):258-69. doi: 10.1111/j.1464-410x.1973.tb12152.x. No abstract available.
PubMed 4712834Kjaer M, Frederiksen PL, Engelholm SA. Postoperative radiotherapy in stage II and III renal adenocarcinoma. A randomized trial by the Copenhagen Renal Cancer Study Group. Int J Radiat Oncol Biol Phys. 1987 May;13(5):665-72. doi: 10.1016/0360-3016(87)90283-5.
PubMed 3553111Naito S, Kumazawa J, Omoto T, Iguchi A, Sagiyama K, Osada Y, Hiratsuka Y. Postoperative UFT adjuvant and the risk factors for recurrence in renal cell carcinoma: a long-term follow-up study. Kyushu University Urological Oncology Group. Int J Urol. 1997 Jan;4(1):8-12. doi: 10.1111/j.1442-2042.1997.tb00130.x.
PubMed 9179659Pizzocaro G, Piva L, Colavita M, Ferri S, Artusi R, Boracchi P, Parmiani G, Marubini E. Interferon adjuvant to radical nephrectomy in Robson stages II and III renal cell carcinoma: a multicentric randomized study. J Clin Oncol. 2001 Jan 15;19(2):425-31. doi: 10.1200/JCO.2001.19.2.425.
PubMed 11208835Rosenberg SA, Yang JC, Topalian SL, Schwartzentruber DJ, Weber JS, Parkinson DR, Seipp CA, Einhorn JH, White DE. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2. JAMA. 1994 Mar 23-30;271(12):907-13.
PubMed 8120958Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995 Mar;13(3):688-96. doi: 10.1200/JCO.1995.13.3.688.
PubMed 7884429Fisher RI, Rosenberg SA, Fyfe G. Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S55-7.
PubMed 10685660Margolin KA, Rayner AA, Hawkins MJ, Atkins MB, Dutcher JP, Fisher RI, Weiss GR, Doroshow JH, Jaffe HS, Roper M, et al. Interleukin-2 and lymphokine-activated killer cell therapy of solid tumors: analysis of toxicity and management guidelines. J Clin Oncol. 1989 Apr;7(4):486-98. doi: 10.1200/JCO.1989.7.4.486.
PubMed 2647914Belldegrun A, Webb DE, Austin HA 3rd, Steinberg SM, White DE, Linehan WM, Rosenberg SA. Effects of interleukin-2 on renal function in patients receiving immunotherapy for advanced cancer. Ann Intern Med. 1987 Jun;106(6):817-22. doi: 10.7326/0003-4819-106-6-817.
PubMed 3495213
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00003126
- Acronym / sponsor ID
- 852006
- Conditions
- Kidney Cancer
- Keywords
- renal cell cancer, renal cell carcinoma, interleukin-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- Chiron Corporation
- Study start
- Jun 1997
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 28 Oct 2003 (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 purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
Detailed description
The primary objective of this prospective, randomized, controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.
Patients are stratified according to their disease classification and randomized to one course of IL-2 [600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28 doses)] or observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interleukin-2 (IL-2) | Experimental | Drug: Interleukin-2Patients randomized to this arm will receive one course of IL-2 [600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)]. |
| Observation | No intervention | –Patients randomized to this arm will receive their normal medical care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.
- Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing.
- No history or evidence of cardiac disease on ECG
- No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment.
Key exclusion criteria (1 listed)
- Age younger than 16
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-2Also: IL-2, AldesleukinHigh-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC | Drug | Interleukin-2 (IL-2) |
Primary outcome
Disease free survival
Time frame: 60 months
Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up.
1 secondary outcome
Overall survival
Time frame: 60 months
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 4 Jan 2017.
- Background: PubMed 12568441Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5.
- Background: PubMed 5125665Skinner DG, Colvin RB, Vermillion CD, Pfister RC, Leadbetter WF. Diagnosis and management of renal cell carcinoma. A clinical and pathologic study of 309 cases. Cancer. 1971 Nov;28(5):1165-77. doi: 10.1002/1097-0142(1971)28:53.0.co;2-g. No abstract available.
- Background: PubMed 28012766Robson CJ, Churchill BM, Anderson W. The Results of Radical Nephrectomy for Renal Cell Carcinoma. J Urol. 2017 Feb;197(2S):S111-S113. doi: 10.1016/j.juro.2016.10.095. Epub 2016 Dec 21. No abstract available.
- Background: PubMed 10561319Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. doi: 10.1200/JCO.1999.17.8.2530.
- Background: PubMed 12663707Messing EM, Manola J, Wilding G, Propert K, Fleischmann J, Crawford ED, Pontes JE, Hahn R, Trump D; Eastern Cooperative Oncology Group/Intergroup trial. Phase III study of interferon alfa-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern Cooperative Oncology Group/Intergroup trial. J Clin Oncol. 2003 Apr 1;21(7):1214-22. doi: 10.1200/JCO.2003.02.005.
- Background: PubMed 7081138Poster DS, Bruno S, Penta JS, Pinna K, Vilk P, Macdonald JS. Current status of chemotherapy, hormonal therapy, and immunotherapy in the treatment of renal cell carcinoma. Am J Clin Oncol. 1982 Feb;5(1):53-60.
- Background: PubMed 4712834Finney R. The value of radiotherapy in the treatment of hypernephroma--a clinical trial. Br J Urol. 1973 Jun;45(3):258-69. doi: 10.1111/j.1464-410x.1973.tb12152.x. No abstract available.
- Background: PubMed 3553111Kjaer M, Frederiksen PL, Engelholm SA. Postoperative radiotherapy in stage II and III renal adenocarcinoma. A randomized trial by the Copenhagen Renal Cancer Study Group. Int J Radiat Oncol Biol Phys. 1987 May;13(5):665-72. doi: 10.1016/0360-3016(87)90283-5.
- Background: PubMed 9179659Naito S, Kumazawa J, Omoto T, Iguchi A, Sagiyama K, Osada Y, Hiratsuka Y. Postoperative UFT adjuvant and the risk factors for recurrence in renal cell carcinoma: a long-term follow-up study. Kyushu University Urological Oncology Group. Int J Urol. 1997 Jan;4(1):8-12. doi: 10.1111/j.1442-2042.1997.tb00130.x.
- Background: PubMed 11208835Pizzocaro G, Piva L, Colavita M, Ferri S, Artusi R, Boracchi P, Parmiani G, Marubini E. Interferon adjuvant to radical nephrectomy in Robson stages II and III renal cell carcinoma: a multicentric randomized study. J Clin Oncol. 2001 Jan 15;19(2):425-31. doi: 10.1200/JCO.2001.19.2.425.
- Background: PubMed 8120958Rosenberg SA, Yang JC, Topalian SL, Schwartzentruber DJ, Weber JS, Parkinson DR, Seipp CA, Einhorn JH, White DE. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2. JAMA. 1994 Mar 23-30;271(12):907-13.
- Background: PubMed 7884429Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995 Mar;13(3):688-96. doi: 10.1200/JCO.1995.13.3.688.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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.
Joseph I. Clark, MD principal investigator
Loyola University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interleukin-2 in people with Kidney Cancer, run by Loyola University at 15 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 8 inclusion and 1 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Disease free survival (time frame: 60 months). 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 NCT00003126, which also lists 25 linked publications.
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 4 Jan 2017.