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Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00019357
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : April 29, 2015
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: aldesleukin Biological: therapeutic autologous lymphocytes Biological: therapeutic tumor infiltrating lymphocytes Phase 1

Detailed Description:

OBJECTIVES: I. Determine the feasibility of expansion and the reinfusion of specific T-cell lines (peptide-specific activated lymphocytes), in combination with interleukin-2, in patients who were vaccinated with ras peptides. II. Assess immunologic status or antitumor response that may occur with this treatment in these patients.

OUTLINE: Autologous peptide-specific activated lymphocytes (PAL), previously harvested from the patient following vaccination on a different protocol, are expanded and reinfused intravenously; this is followed by a 4 hour observation period. Patients then receive interleukin-2 (IL-2) administered subcutaneously 5 days a week for 2 weeks; the first dose of IL-2 is administered at least 4 hours after PAL infusion. Patients are followed once a month for 2 months after treatment.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Cellular Immunotherapy With Autologous T Lymphocytes Stimulated With the Patient's Tumor-Specific Mutated Ras Peptides
Study Start Date : June 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00019357

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United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Samir N. Khleif, MD National Cancer Institute (NCI)

Layout table for additonal information Identifier: NCT00019357     History of Changes
Obsolete Identifiers: NCT00001583
Other Study ID Numbers: CDR0000065811
First Posted: April 22, 2004    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: August 2001

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
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Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents