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Cellular Immunotherapy With Autologous T Lymphocytes Stimulated With the Patient's Tumor-Specific Mutated Ras Peptides

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Cellular Immunotherapy With Autologous T Lymphocytes Stimulated With the Patient's Tumor-Specific Mutated Ras Peptides

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Samir N. Khleif, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific



Medicine Branch Bethesda, Maryland  20892