Phase 2 N=123 Treatment

The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT00554515 ↗

Enrolled (actual)

123

Serious AEs

12.5%

Results posted

May 2017

Primary outcome: Primary: Objective Response in ISM Good Risk Group — .23 proportion of participants — p=0.042

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: HD IL2 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response in ISM Good Risk Group	.23	0.042 sig
SECONDARY Objective Response Rate in ISM Poor Risk Group	.23	0.39
SECONDARY Objective Response Rate (Independent Assessment)	.25	0.0014 sig
SECONDARY Overall Survival	42.8	—
SECONDARY 3-Year Progression-Free Survival Rate	.108	—
SECONDARY Objective Response Rate by MSKCC Risk Group	.22; .25; .31	.89
SECONDARY Objective Response Rate by UCLA SANI Score	.20; .27; .00	—
SECONDARY Objective Response Rate by Tumor Type	.26; .00	.33
SECONDARY Objective Response Rate by Clear Cell Histology Risk Group	.27; .24; .28	.89
SECONDARY Objective Response Rate by CA-9 Score (CAIX Classification)	.33; .22	.19
SECONDARY Objective Response Rate by PD-L1 Tumor	.19; .50	0.01 sig
SECONDARY Objective Response Rate by B7-H3 Tumor	.11; .29	.08
SECONDARY Objective Response Rate by CA-9 SNP	.20; .33	.28
SECONDARY Progression-Free Survival	4.2	—

Summary

High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug Administration (FDA) for the treatment of metastatic kidney cancer and is a standard treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer that can produce a remission of disease that lasts after treatment is completed. However, most patients who receive IL-2 do not benefit and all patients experience potentially dangerous side effects. Recent research has suggested that certain patients may respond better to IL-2 than others. The Cytokine Working Group is currently conducting a clinical trial that aims to identify and confirm this research and narrow the application of IL-2 to those patients most likely to benefit.

Eligibility Criteria

Inclusion Criteria

Patients must have histologically confirmed renal cell carcinoma that is metastatic or unresectable.
If patients have measurable disease restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
Patients must provide access to tissue blocks containing adequate tumor for interpretation and analysis.
Patients must have measurable disease.
Patients must have good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).
Patients must have adequate organ function.
Patients must have no contraindication of vasopressor agents.
Patients must be ≥ 18 years of age.

Exclusion Criteria

Patients who have received systemic therapy for metastatic disease.
Patients with organ allografts.
Patients who require or are likely to require systemic corticosteroid therapy for intercurrent illness.
Patients with any significant medical disease other than the malignancy (e.g. COPD, patients with ascites or pleural effusions), which in the opinion of the investigator would significantly increase the risk of immunotherapy.
Patients with a history of another malignancy within the past 5 years other than surgically cured non-melanoma skin cancer, carcinoma-in-situ or Stage I carcinoma of the cervix.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00554515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.