- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00030342
Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
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
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Hva måler studien?
Primære resultatmål
Resultatmål |
|---|
|
Overlevelse målt ved Kaplan-Meier-metoden ved 5 år
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Response as measured by RECIST guidelines and Kaplan-Meier method at 5 years
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Safety as measured by NCI common toxicity table at study completion
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: John P. Hanson, MD, St. Luke's Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Adenokarsinom
- Karsinom
- Neoplasmer, kjertel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Nyre-neoplasmer
- Karsinom, nyrecelle
- Kolorektale neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Interferoner
- Interferon-alfa
- Fluorouracil
- Sargramostim
Andre studie-ID-numre
- STLMC-IMM-0104
- CDR0000069153 (Registeridentifikator: PDQ (Physician Data Query))
- STLMC-L-01108
- NCI-V01-1686
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