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Interleukin 12-Primed Activated T Cells For Patients With Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma (Phase I)

Phase 1
18 Years
Open (Enrolling)
Colorectal Cancer, Kidney Cancer

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Trial Information

Interleukin 12-Primed Activated T Cells For Patients With Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma (Phase I)

OBJECTIVES: I. Determine the safety of fluorouracil and interleukin-12-primed activated T
cells (12ATC) with sargramostim (GM-CSF) and interferon alfa in patients with metastatic
renal cell cancer or colorectal cancer. II. Determine the maximum tolerated dose of 12ATC in
this patient population. III. Determine the clinical response of patients treated with this

OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and undergo
leukopheresis on day 6 to obtain peripheral blood mononuclear cells (PBMC). Patients treated
at dose level 3 also undergo leukopheresis on day 7. The PBMC are treated with monoclonal
antibody anti-CD3, interleukin-12 and interleukin-2 to form 12ATC. Patients receive
chemo/immunotherapy comprising fluorouracil IV continuously over 24 hours on day 13 and
GM-CSF and interferon alfa SC on days 17, 19, 21, 24, 26, and 28. Patients receive 12ATC IV
over 15-30 minutes on days 31, 34, 38, 41, 45, and 48 and interferon alfa SC on days 35, 42,
and 49. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks,
every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma or
colorectal carcinoma Failed prior standard or salvage therapy OR Ineligible for standard
therapy due to concurrent illness OR Declined standard therapy Bidimensionally measurable
disease (by CT scan or MRI) outside prior irradiation port unless documented disease
progression after radiotherapy No untreated or unstable treated brain metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
More than 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least
100,000/mm3 Total granulocyte count at least 2,000/mm3 Hemoglobin at least 10 g/dL No
coagulation disorders such as thrombophlebitis Hepatic: Bilirubin no greater than 2.5
mg/dL SGOT/SGPT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less
than 3 times ULN PT/PTT no greater than 1.5 times control Hepatitis B surface antigen
negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemia
and/or ejection fraction less than 45% No unstable angina No uncontrolled congestive heart
failure Pulmonary: FEV1 or FVC greater than 65% of predicted No uncontrolled pulmonary
embolism Other: No other prior malignancy within the past 5 years except resected basal
cell carcinoma or carcinoma in situ of the cervix No active systemic infection No
autoimmune disease No uncontrolled thyroid abnormalities No other major medical illness
HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: More than 1 month
since prior biologic therapy or immunotherapy Chemotherapy: More than 1 month since prior
chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: At least 4 weeks
since prior steroid therapy or steroid-containing compounds At least 2 weeks since prior
topical or inhaled steroids No concurrent steroids Radiotherapy: More than 1 month since
prior radiotherapy, interstitial brachytherapy, or radiosurgery Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John P. Hanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Luke's Medical Center


United States: Federal Government

Study ID:




Start Date:

January 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Kidney Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Colorectal Neoplasms



St. Luke's Medical Center Milwaukee, Wisconsin  53215