Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	Other	STLMC-IMM-0104 L-01-108, STLMC-L-01108, NCI-V01-1686, NCT00030342

Objectives

1. 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.
2. Determine the clinical responses of patients treated with this regimen.
3. Determine the efficacy of 12ATC in these patients.
4. Determine whether there are changes in immunologic parameters related to 12ATC as measured by lymphocyte phenotype and cytokine secretion in these patients.
5. Determine the correlation between clinical responses in patients treated with this regimen and in vitro immune functions of lymphocytes.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 4,000/mm³
• Granulocyte count at least 2,000/mm³
• Platelet count at least 100,000/mm³
• 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:

• FEV₁ 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

Expected Enrollment

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

Outcomes

Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years
Survival as measured by the Kaplan-Meier method at 5 years
Safety as measured by NCI common toxicity table at study completion

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.

Trial Contact Information

Trial Lead Organizations

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

John Hanson, MD, Protocol chair		Ph: 414-649-5818; 800-252-2990 Email: jphanson@cancerrx.com

Registry Information
Official Title		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
Trial Start Date		2001-11-03
Trial Completion Date		2007-10-08
Registered in ClinicalTrials.gov		NCT00030342
Date Submitted to PDQ		2001-11-15
Information Last Verified		2008-10-29

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