NCT00304460

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2014

Completed
Last Updated

December 12, 2019

Status Verified

February 27, 2014

Enrollment Period

8 years

First QC Date

March 16, 2006

Last Update Submit

December 11, 2019

Conditions

Metastatic MelanomaRenal Cell Cancer

Keywords

Serum Protein LevelsLymphocyte PhenotypesPredictive AnalysisSerum CytokinesKidney CancerRenal Cell CancerMelanomaMetastatic Melanoma

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome as measured by RECIST

Interventions

aldesleukinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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. doi: 10.3322/canjclin.50.4.215.

    PMID: 10986965BACKGROUND

  • Lin JX, Leonard WJ. Signaling from the IL-2 receptor to the nucleus. Cytokine Growth Factor Rev. 1997 Dec;8(4):313-32. doi: 10.1016/s1359-6101(97)00021-x.

    PMID: 9620644BACKGROUND

  • 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.

    PMID: 2945603BACKGROUND

MeSH Terms

Conditions

MelanomaCarcinoma, Renal CellKidney Neoplasms

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • James C Yang, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

March 13, 2006

Primary Completion

February 27, 2014

Study Completion

February 27, 2014

Last Updated

December 12, 2019

Record last verified: 2014-02-27

Locations

US(1)