Clinical trial · Interventional
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
NCT00445523CI-TRIAL-00021404completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax® will delay tumor progression.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon-alpha | Drug | — | UNRESOLVED |
| TroVax® (Immunological Vaccine Therapy) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- TroVax® alone
- interventionNames
- Biological: TroVax® (Immunological Vaccine Therapy)
- type
- EXPERIMENTAL
- label
- 2
- description
- TroVax® plus IFN-α
- interventionNames
- Biological: TroVax® (Immunological Vaccine Therapy)
- Drug: Interferon-alpha
Primary outcomes (1)
- measure
- Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.
- timeFrame
- restaging every 9 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.