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

NCT ID: NCT00030342

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2008-01-31

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of biological therapy combined with chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.

Detailed Description

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.

Conditions

Colorectal Cancer; Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

recombinant interferon alfa

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

therapeutic autologous lymphocytes

Intervention Type: BIOLOGICAL

fluorouracil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Luke's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

John P. Hanson, MD

Role: STUDY_CHAIR

St. Luke's Medical Center

Locations

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

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

CDR0000069153

Identifier Type: REGISTRY

Identifier Source: secondary_id

STLMC-L-01108

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1686

Identifier Type: -

Identifier Source: secondary_id

STLMC-IMM-0104

Identifier Type: -

Identifier Source: org_study_id