NCT00019357

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining white blood cells, which have been activated by a vaccine, with interleukin-2 may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus activated white blood cells in treating patients with cancer that has not responded to chemotherapy or radiation therapy.

Trial Health

80
On Track

Trial Health Score

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

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

June 1, 1998

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
Last Updated

April 29, 2015

Status Verified

August 1, 2001

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

aldesleukinBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
therapeutic tumor infiltrating lymphocytesBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Patients must be enrolled to be treated with mutated ras peptides vaccine on another protocol Malignant disease for which no further chemotherapy or radiation options to increase survival are available No history of CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL SGOT or SGPT no greater than 4 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemic heart disease (i.e., NYHA class III or IV cardiac disease) No myocardial infarction within past 6 months No history of congestive heart failure No ventricular arrhythmias or other arrhythmias requiring therapy Other: HIV negative No hepatitis B or C infection No active infection requiring antibiotics No history of autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, or active Graves' disease) No active second malignancy other than curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior steroids and recovered No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Interventions

aldesleukin

Study Officials

  • Samir N. Khleif, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

April 22, 2004

Study Start

June 1, 1998

Last Updated

April 29, 2015

Record last verified: 2001-08

Locations

US(1)