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The High-Dose Aldesleukin (IL-2) "Select" Trial: A Trial Designed to Prospectively Validate Predictive Models of Response to High Dose IL-2 Treatment in Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma

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Trial Information

The High-Dose Aldesleukin (IL-2) "Select" Trial: A Trial Designed to Prospectively Validate Predictive Models of Response to High Dose IL-2 Treatment in Patients With Metastatic Renal Cell Carcinoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine, in a prospective fashion, if the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "good" pathologic predictive features is significantly higher than a historical, unselected patient population

Outcome Time Frame:

months

Safety Issue:

No

Principal Investigator

David F McDermott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

DFHCC 06-149

NCT ID:

NCT00554515

Start Date:

November 2006

Completion Date:

November 2009

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Kidney
  • Renal Cell
  • Metastatic
  • interleukin-2
  • select
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215