Safety Study of TroVax Alone vs. TroVax Plus Interferon Alpha in Patients With Renal Cancer

NCT00445523 | Completed Phase 2

• 2 other identifiers: HMRI IRB#0206-0028TV2/002/06
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carcinoma, Renal Cell

Keywords

Advanced renal cancer; metastatic renal cancer; RCC; kidney cancer; M3thodist

Outcome Measures

Primary Outcomes (1)

• Tumor objective response rate by RECIST criteria to TroVax® and TroVax® in combination with IFN-α.

  restaging every 9 weeks

Secondary Outcomes (3)

• Overall survival

  restaging every 9 weeks

• Progression-free survival

  restaging every 9 weeks

• Time to Progression

  restaging every 9 weeks

Study Arms (2)

1

EXPERIMENTAL

TroVax® alone

Biological: TroVax® (Immunological Vaccine Therapy)

2

EXPERIMENTAL

TroVax® plus IFN-α

Biological: TroVax® (Immunological Vaccine Therapy); Drug: Interferon-alpha

Interventions

TroVax® (Immunological Vaccine Therapy) BIOLOGICAL

16 Intramuscular injections of TroVax® over 47 weeks

1; 2

Interferon-alpha DRUG

36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)

Also known as: Intron

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Oxford BioMedica: collaborator

Study Sites (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

TroVax; Interferon-alpha; Introns

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Robert J Amato, DO

  Baylor College of Medicine - Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 9, 2007
• Study Start: May 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)