Protocol Number: 06-C-0115

Title:

Studies on the Mechanism of Action of High-dose IL-2 in Metastatic Melanoma and Renal Cell Cancer

Number:

06-C-0115

Summary:

Background:

-Although IL-2 can shrink tumors in about 20 percent of patients with metastatic kidney cancer and in 15 percent of patients with metastatic melanoma, it is not fully known how the drug works.

Objectives:

-To better understand how IL-2 causes tumors to shrink.

Eligibility:

-Patients 18 years of age or older with metastatic kidney cancer or metastatic melanoma

Design:

-135 patients with melanoma and 110 patients with kidney cancer may be enrolled.

-Patients are hospitalized for about 7 days for each treatment. They receive IL-2 intravenously (through a vein) over 15 minutes every 8 hours for up to 4 days or 12 doses. This constitutes one treatment cycle.

-Research blood samples are collected daily during the first treatment cycle and for one or two days following the last dose.

-Patients may be asked to undergo leukapheresis, a procedure for collecting large quantities of white blood cells. This involves collecting blood through a needle in an arm vein. The blood is directed through a cell separator where the white cells are extracted. The rest of the blood (red cells, platelets, and plasma) is returned to the patient through the same needle or through a needle in the other arm.

-About 7-10 days after discharge from the hospital, patients return for a second treatment cycle but without research blood sampling.

-2 months after therapy, patients are evaluated with scans, and x-rays, and blood tests to evaluate the tumor and the effects of the treatment on immune cells.

-Patients whose tumors shrink or remain stable may continue treatment (without repeating the full set of research blood samples) as long as they benefit from the treatment and do not develop unacceptable side effects. Patients who continue treatment are evaluated every 2 months for 3 to 4 times and then every 3 to 6 months.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

- Any patient with metastatic, measurable, histologically-proven RCC or melanoma who is a candidate for high-dose IL-2 therapy.

- Expected survival greater than three months.

- Age greater than or equal to18 years old.

- ECOG less than 2.

- Serum creatinine less than or equal to 1.4 mg/dl or creatinine clearance greater than or equal to 90 mL/min, and total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

- Platelet count greater than 100,000/mm(3).

- Absolute neutrophil count greater than 1000/mm(3).

- Serum ALT/AST less than three times the upper limit of normal.

- Must be willing to sign a durable power of attorney.

- Must be willing to practice effective contraception (regardless of gender).

- Must be willing to sign the informed consent document.

EXCLUSION CRITERIA:

- Significant second malignancy within 3 years of protocol entry or likely to require intervention in the year following protocol entry.

- Significant psychiatric disease which in the opinion of the Principal Investigator would prevent adequate informed consent or render immunotherapy unsafe or contraindicated.

- Requirement for systemic or inhaled steroid administration (topical therapy is acceptable).

- Prior therapy within 28 days (except focal radiation for bone lesion).

- Systemic infections, coagulation disorders or evidence of active bleeding, or other major medical illnesses of the cardiovascular, respiratory or immune system.

- ECOG performance status greater than 2.

- Pregnancy.

-Previous IL-2 therapy.

- Positive HIV antibody titer, Seropositive for hepatitis B or C antigen.

- FEV1 or VC less than or equal to 65% of predicted (pulmonary function screening to be done in patients with significant smoking history [greater than 20pk/years] or suspicion of pulmonary disease by history or examination).

- Abnormal stress cardiac exam (to be done in all patients greater than or equal to 60 years old and others as indicated clinically) or active cardiac ischemia or significantly abnormal EKG.

- Greater than 25% estimated hepatic replacement by tumor or SGOT or SGPT greater than 3x normal.

- Untreated or clinically significant (i.e. because of size or presence of edema) tumor involvement of the CNS or major nerve compression.

Special Instructions:

Currently Not Provided

Keywords:

Serum Protein Levels

Lymphocyte Phenotypes

Predictive Analysis

Serum Cytokines

Recruitment Keyword(s):

Kidney Cancer

Renal Cell Cancer

Melanoma

Metastatic Melanoma

Condition(s):

Metastatic Melanoma

Renal Cell Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Low dose IL-2

Supporting Site:

National Cancer Institute

Contact(s):

Recruitment Center - SB
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Building 10, Room 2-1730, Bethesda, Maryland 20892, United States
Phone: (866) 820-4505
Fax: (301) 451-1927
Electronic Address: ncisbirc@mail.nih.gov

Citation(s):

Rigel DS, Carucci JA. Malignant melanoma: prevention, early detection, and treatment in the 21st century. CA Cancer J Clin. 2000 Jul-Aug;50(4):215-36; quiz 237-40.

Lin JX, Leonard WJ. Signaling from the IL-2 receptor to the nucleus. Cytokine Growth Factor Rev. 1997 Dec;8(4):313-32.

Koizumi S, Seki H, Tachinami T, Taniguchi M, Matsuda A, Taga K, Nakarai T, Kato E, Taniguchi N, Nakamura H. Malignant clonal expansion of large granular lymphocytes with a Leu-11+, Leu-7- surface phenotype: in vitro responsiveness of malignant cells to recombinant human interleukin 2. Blood. 1986 Nov;68(5):1065-73.

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