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Details for trial 0I-05-2

Description:	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.
Status:	Closed
Randomized?	No

Researchers

Principal Investigator	Title
David Quinn	M.D.

Data Management

Name	Title
Charlean Ketchens	D.M.
Lagrimas Ilagan	D.M.
Roberto Tejada	D.M.
Carrie Korn	R.N.

You may participate in this study if:

	Requirement
1	Subjects must have histologically confirmed renal cell carcinoma or melanoma that is metastatic or unresectable and that is clearly progressive;
2	Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
3	Age greater than or equal to 18 years old including males and females;
4	Performance Status ECOG: 0 or 1 (Karnofsky greater than or equal to 80%);
5	Subjects must have adequate organ function as defined by: • White Blood Cell Count (WBC) greater than or equal to 4000, platelet (PLT) greater than or equal to 100,000, and hemoglobin (HGB) greater than or equal to 10 ; • Serum creatinine less than or equal to 1.25x ULN or creatinine clearance greater than or equal to 45 by the Cockcroft Gault method; • Total bilirubin less than or equal to 1.5 ; • Adequate pretreatment cardiopulmonary function in accordance with product label and institutional practice;
6	Radiotherapy, if needed for local control or palliative therapy, must have been completed 21 days prior to subject entry into this protocol and subjects must have recovered from the side effects of therapy;
7	Subjects must have discontinued previous anticancer or investigational therapy and have recovered fully from the toxic effects of that treatment;
8	A period of 28 days must have elapsed after major surgery;
9	For women of childbearing potential, a negative serum pregnancy test within 14 days of treatment and maintained use of a physician-approved method of birth control throughout the study.

You may not participate in this study if:

1	Prior treatment with any form of IL-2;
2	Clinically significant cardiac, pulmonary, thyroid, kidney or neurologic impairment, hemostatic disorder, or significant medical condition that would, in the opinion of the investigator, affect the subject's safety and/or compliance. This includes, but is not necessarily limited to, autoimmune disease, inflammatory bowel disease, psoriasis, preexisting arrhythmia, congestive heart failure, ischemic heart disease, cardiomyopathy, uncontrolled diabetes mellitus, or serious and uncontrolled active infection;
3	Subjects with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs that results in impairment of pulmonary function;
4	Contraindication to the use of vasopressor agents;
5	Uncontrolled CNS metastases;
6	Known positive serology for HIV;
7	Use of corticosteroids for immunosuppression (if patient had been taking steroids, at least 2 weeks must have passed since last dose);
8	Patients with organ allograft.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.