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A Phase I/II Study Of Interleukin-12-Primed Activated T Cells In Combination With 5FU, GM-CSF And Interferon Alfa-2b In Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Kidney Cancer

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Trial Information

A Phase I/II Study Of Interleukin-12-Primed Activated T Cells In Combination With 5FU, GM-CSF And Interferon Alfa-2b In Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma


OBJECTIVES:

- Determine the safety of a repeat course of interleukin-12-primed activated T cells
(12ATC) in combination with fluorouracil, sargramostim (GM-CSF), and interferon alfa-2b
in patients with metastatic renal cell or colorectal carcinoma.

- Determine the clinical responses of patients treated with this regimen.

- Determine the efficacy of 12ATC in these patients.

- Determine whether there are changes in immunologic parameters related to 12ATC as
measured by lymphocyte phenotype and cytokine secretion in these patients.

- Determine the correlation between clinical responses in patients treated with this
regimen and in vitro immune functions of lymphocytes.

OUTLINE: Patients are stratified according to disease type (renal cell carcinoma vs
colorectal carcinoma).

Patients receive sargramostim (GM-CSF) subcutaneously (SC) daily on days 1-5 and then
undergo collection of autologous peripheral blood mononuclear cells (PBMC) on days 6 and 7
of week 1. The PBMC are treated ex vivo to form interleukin-12-primed activated T cells
(12ATC).

Patients receive fluorouracil IV over 24 hours on day 6 of week 2 and interferon alfa-2b SC
and GM-CSF SC 3 times weekly on weeks 3-5. Patients receive 12ATC IV over 15-30 minutes
twice weekly and interferon alfa-2b SC (at least 24 hours after 12ATC infusion) once weekly
on weeks 6-8. Patients with complete or partial response or stable disease at 3 weeks after
the last 12ATC infusion may receive an additional 8-week course as above.

Patients are followed every 2-3 months for 1 year and then every 6 months for 2 years or at
any time when the physical examination or symptoms are suspicious for tumor progression.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study
within 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic renal cell carcinoma or
colorectal carcinoma, meeting 1 of the following criteria:

- Obtained no benefit from prior standard or salvage therapy

- Ineligible for standard therapy because of concurrent illness

- Declined standard therapy

- At least 1 site of measurable disease that can be measured in at least 1 dimension

- At least 20 mm with conventional techniques OR at least 10 mm with spiral CT
scan

- 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/mm^3

- Granulocyte count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

- No coagulation disorders

Hepatic:

- Bilirubin no greater than 2.5 mg/dL*

- ALT/AST less than 3 times upper limit of normal*

- PT no greater than 1.5 times control (unless therapeutically anticoagulated)

- PTT less than 1.5 times control (unless therapeutically anticoagulated) NOTE:
*Patients whose cancer has led to values that do not fall within the above ranges may
be eligible at the discretion of the investigators

Renal:

- Creatinine no greater than 2.0 mg/dL* NOTE: *Patients whose cancer has led to values
that do not fall within the above range may be eligible at the discretion of the
investigators

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No thrombophlebitis

Pulmonary:

- FEV_1 and FVC at least 65% predicted

- No uncontrolled pulmonary embolism

Other:

- No other malignancy within the past 5 years except resected basal cell skin cancer or
carcinoma in situ of the cervix

- No prior allergic reactions attributed to compounds of similar chemical or biologic
composition to interleukin-12-primed activated T cells or other study agents

- No active autoimmune disease

- No uncontrolled thyroid abnormalities

- No ongoing or active infection

- No other uncontrolled concurrent illness

- No psychiatric illness or social situations that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 2 years after
study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- More than 4 weeks since prior immunotherapy

Chemotherapy:

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

Endocrine therapy:

- At least 4 weeks since prior steroid therapy or steroid-containing compounds

- At least 2 weeks since prior topical or inhaled steroids

Radiotherapy:

- More than 4 weeks since prior radiotherapy and recovered

Surgery:

- More than 4 weeks since prior major surgery

Other:

- No other concurrent investigational agents

- No other concurrent commercial anticancer agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years

Safety Issue:

No

Principal Investigator

John P. Hanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Luke's Medical Center

Authority:

United States: Federal Government

Study ID:

STLMC-IMM-0104

NCT ID:

NCT00030342

Start Date:

November 2001

Completion Date:

January 2008

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

Name

Location

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901