- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine - Methodist Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
TroVax® alone
|
16 Intramuscular injections of TroVax® over 47 weeks
|
Experimentell: 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)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.
Tidsram: restaging every 9 weeks
|
restaging every 9 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Overall survival
Tidsram: restaging every 9 weeks
|
restaging every 9 weeks
|
Progression-free survival
Tidsram: restaging every 9 weeks
|
restaging every 9 weeks
|
Time to Progression
Tidsram: restaging every 9 weeks
|
restaging every 9 weeks
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Robert J Amato, DO, Baylor College of Medicine - Methodist Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urologiska neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Njursjukdomar
- Urologiska sjukdomar
- Adenocarcinom
- Carcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i njurarna
- Karcinom, njurcell
- Läkemedels fysiologiska effekter
- Anti-infektionsmedel
- Antivirala medel
- Antineoplastiska medel
- Immunologiska faktorer
- Interferoner
- Interferon-alfa
- Vacciner
Andra studie-ID-nummer
- HMRI IRB#0206-0028
- TV2/002/06
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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