- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00445523
Safety Study of TroVax Alone vs. TroVax Plus Interferon Alpha in Patients With Renal Cancer
A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Interferon Alfa (IFN-α) on Patients With Advanced or Metastatic Renal Cell Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients with metastatic renal cell cancer will be enrolled in the study if all inclusion/exclusion criteria are met. Once the patient is enrolled, and baseline tests have been completed, the patient will start treatment.
Trovax® alone arm:
Trovax will be given as an intramuscular injection every two weeks for the first two months, then once a month for the next 2 months, and then once every 2 months for up to a year.
Trovax® plus IFN-α:
Trovax® schedule will be the same as the Trovax® alone arm. IFN will be given on the first, third and fifth day of the week for a total of twelve weeks.
At every office visit vital signs will be taken. Every eight weeks a medical history, physical exam, performance status evaluation, chest x-ray or CT scan, abdomen/pelvis CT scan or MRI will be done. A blood sample (about 8-10 tablespoons) will be taken to test the immunological response to TroVax® on the same days that the patient receives TroVax® injections.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine - Methodist Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Locally advanced or metastatic histologically confirmed clear cell or papillary cell renal carcinoma.
- Primary tumor surgically removed.
- Stable or progressive disease as defined by RECIST criteria.
- Age ≥ 18 years.
- At least one prior standard of care therapy (IL-2, IFN-α, or approved kinase inhibitor)
- At least four weeks from prior use of standard of care therapy.
- Karnofsky performance status ≥ 80%.
- Corrected Serum Calcium ≥ 10 g/dL.
- Patients on stable doses of bisphosphonates (Fosamax, Actonel, Didrocal) that show subsequent tumor progression may continue on this medication; however patients are not allowed to start bisphosphonates within one month prior to starting trial, or throughout the duration of the trial.
- Major surgery or radiation therapy completed ≥ 4 weeks prior to treatment.
- Clinically immunocompetent.
- Free of clinically apparent autoimmune disease.
- Absolute lymphocyte count ≥ 500/μL, Absolute neutrophil count ≥ 1200/μL, Platelet count ≥ 100,000/μl, Hemoglobin ≥ 9mg/dL.
- No evidence of active ischemia on Electrocardiogram (ECG)
- Women must be either post-menopausal, rendered surgically sterile, or using reliable form of contraceptive.
- Able to give informed consent and comply with the protocol.
Exclusion Criteria:
- Prior treatment with TroVax®
- No supplements of complementary medicines/botanicals are permitted during study, except for any combination of the following: multivitamins, selenium, lycopene, soy supplements, Vitamin E.
- Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
- Participation in any other clinical trial within 30 days.
- Cerebral metastasis on MRI Scan.
- Currently active second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse.
- Serious intercurrent infections or nonmalignant medical illnesses which are uncontrolled.
- Psychiatric illnesses that would limit compliance with protocol.
- A history of psychosis or clinical depression.
- Liver function tests (ALT, AST) more than 1.5 X upper limit of normal (ULN). Bilirubin must be within normal limits.
- Creatinine ≥ 1.5 X ULN.
- Known allergy to egg proteins.
- Known allergy to neomycin.
- History of allergic response to previous vaccinia vaccinations.
- Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency.
- Positive for HIV or Hepatitis B or C.
- Clinical indication of reduced cardiac function or an ejection fraction of ≤ 40%.
- Pregnancy or lactation
- Current chemotherapy, immunotherapy, radiation therapy, or the requirement for radiotherapy.
- No investigational or commercial agents or therapies other that those included in the protocol treatment may be administered with the intent to treat malignancy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
TroVax® alone
|
16 Intramuscular injections of TroVax® over 47 weeks
|
Eksperimentel: 2
TroVax® plus IFN-α
|
16 Intramuscular injections of TroVax® over 47 weeks
36 subcutaneous IFN-α injections for 12 weeks.
sc injection three times per week (5MU each)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.
Tidsramme: restaging every 9 weeks
|
restaging every 9 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall survival
Tidsramme: restaging every 9 weeks
|
restaging every 9 weeks
|
Progression-free survival
Tidsramme: restaging every 9 weeks
|
restaging every 9 weeks
|
Time to Progression
Tidsramme: restaging every 9 weeks
|
restaging every 9 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Robert J Amato, DO, Baylor College of Medicine - Methodist Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Karcinom
- Neoplasmer, kirtel og epitel
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antivirale midler
- Antineoplastiske midler
- Immunologiske faktorer
- Interferoner
- Interferon-alfa
- Vacciner
Andre undersøgelses-id-numre
- HMRI IRB#0206-0028
- TV2/002/06
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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