PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer
|First Received Date ICMJE||July 23, 2004|
|Last Updated Date||March 14, 2014|
|Start Date ICMJE||July 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||For the Ovarian Cancer and Breast Cancer arms: To evaluate clinical response to the vaccine.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00088413 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To evaluate immune response generated by this combination therapy as measure by ELISPOT assay.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer|
|Official Title ICMJE||An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination With Sargramostim in Adults With Metastatic Carcinoma|
Eligibility: Patients 18 years of age and older with advanced cancer whose tumors produce CEA or MUC-1 protein
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Completion Date||December 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
A. Histologically confirmed carcinoma that for patients in the first two arms (colorectal and non-colorectal cancer) is CEA or MUC-1 positive. Tumor that has been shown to express CEA or MUC-1 (greater than or equal to 20 % of cells) by immunohistochemical techniques or patients that have had an elevated serum CEA (greater than 5 microgram/L) at any point during their disease course. For patients in the ovarian and breast cancer arms, as greater than 95% of these express MUC-1 or CEA, we will not require staining prior to coming onto trial.
B. Patients must have completed at least one 5-FU containing chemotherapy regimen (e.g. 5-FU/LV with or without either irinotecan or oxaliplatin) for the colorectal cancer arm, or either failed or not be a candidate for therapy of proven efficacy for their disease in the non-colorectal, breast, and ovarian cancer arms.
C. 18 years of age or greater.
D. All patients on the colorectal adenocarcinoma cohort must be HLA-A2 positive.
E. At least 10 patients on the non-colorectal adenocarcinoma cohort must be HLA-A2 positive.
F. Patients on the breast and ovarian arms are not required to be HLA-A2 positive.
G. For the colorectal and non-colorectal cancer arms (the initial two arms), patients will be required to have: metastatic disease (measurable or evaluable), metastatic disease documented by biopsy but not evaluable by imaging (e.g. small volume peritoneal disease), and patients with surgically resected metastatic disease at high risk of relapse. For the ovarian and breast cancer arms, patients will be required to have evaluable disease.
H. Able to understand and give informed consent.
I. Able to avoid close household contact (close household contacts are those who share housing or have close physical contact) for at least three weeks after recombinant vaccinia vaccination with persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.
J. ECOG performance status of 0 - 1.
K. Serum creatinine not above the institution limits of normal, and AST less than or equal to twice the upper limits of normal OR creatinine clearance on a 24 hour urine collection of greater than or equal to 60 mL/min.
L. Total bilirubin within the institution limits of normal OR patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0
M. Recovered completely from any reversible toxicity associated with recent therapy. Typically this is 3-4 weeks for patients who most recently received cytotoxic therapy except for the nitrosoureas and mitomycin C for which 6 weeks is needed for recovery.
N. Hematological eligibility parameters (within 16 days of starting therapy):
O. Prior immune therapy with related vaccinia and fowlpox vaccines or antigen-specific peptides is allowed.
P. Men and women must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy.
Q. Patients with prostate cancer must continue to receive GnRH agonist therapy (unless orchiectomy has been done).
R. Patients should appear clinically stable (in the opinion of the prinicipal investigator) to complete the full 3 month course of vaccination with an anticipated survival of 6 months or longer.
INCLUSION CRITERIA FOR EXTENSION OR MAINTENANCE PHASE:
A. Completion of Core phase of the protocol.
B. Stable or responding disease (PR, CR).
C. No dose limiting toxicity (see below) in Core phase possibly, probably or definitely related to the vaccine.
Dose limiting toxicities include:
A. Patients should have no evidence of being immunocompromised as listed below.
B. Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses systemic steroids to prevent IV contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed.
C. History of allergy or untoward reaction to prior vaccination with vaccinia virus.
D. Pregnant or breast-feeding women.
E. Altered immune function, including immunodeficiency or history of immunodeficiency; eczema; history of eczema, or other eczematoid skin disorders; or those with acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds).
F. Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis
G. Patients with a history of cardiomyopathy or symptomatic congestive heart failure (unless stable on treatment), symptomatic arrhythmia not controlled by medication. Unstable atherosclerotic heart disease (e.g. unstable angina) who require active intervention and history of myocardial infarction or embolic stroke within the past 6 months.
H. Clinically active brain metastasis, or a history of encephalitis, multiple sclerosis, or seizures within the last year (from seizure disorder or brain metastasis).
I. Medical conditions, which, in the opinion of the investigators would jeopardize the patient or the integrity of the data obtained.
J. Concurrent chemotherapy; an exception to this is to allow for patients with breast cancer who are receiving trastuzumab, to continue therapy with trastuzumab while receiving the vaccine treatment.
K. Serious hypersensitivity reaction to egg products.
L. Clinically significant cardiomyopathy requiring treatment.
M. Chronic hepatitis infection, including B and C, because of potential immune impairment.
N. Although topical steroids are allowed, steroid eye drop are contraindicated.
O. Cardiac complications, including recent myocardial infarction or cerebrovascular accident within one year, and/or unstable or uncontrolled angina.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00088413|
|Other Study ID Numbers ICMJE||040246, 04-C-0246|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP