Vaccine Therapy With or Without Sargramostim in Treating Patients With Cancer
A Phase I Study of Sequential Vaccinations With Fowlpox-CEA(6D)-TRICOM (B7.1/ICAM/LFA-3) Alone, and in Combination With Vaccinia-CEA(6D)-TRICOM, and the Role of GM-CSF, in Patients With CEA Expressing Carcinomas
8 other identifiers
interventional
42
1 country
1
Brief Summary
Phase I trial to compare the effectiveness of vaccine therapy with or without sargramostim in treating patients who have solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Combining colony-stimulating factors such as sargramostim with vaccines may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 2, 2001
CompletedFirst Posted
Study publicly available on registry
February 3, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedMay 16, 2013
May 1, 2013
9.4 years
February 2, 2001
May 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Immunologic response, measured by the frequency of interferon gamma-releasing T cells specific to CAP-1, an HLA-A2 restricted epitope of CEA, as measured by the ELISPOT assay
Pre and post-vaccination CTL precursor frequencies will be calculated so that changes in CTL precursor frequencies can be compared between dose levels of the vaccine. Also, 95% confidence intervals can be calculated for the percent increases (or decreases) in CTL precursor frequencies between dose levels.
Up to 3 months after completion of study treatment
Study Arms (3)
Stage I
EXPERIMENTALPatients receive fCEA-TRI vaccine SC once daily on days 1, 29, 57, and 85.
Stage II
EXPERIMENTALPatients receive vCEA-TRI vaccine intradermally once on day 1 and fCEA-TRI vaccine SC at the MTD determined in stage I once daily on days 29, 57, and 85.
Stage III
EXPERIMENTALA single cohort of 6-10 patients receive both vaccines as in stage II, at the MTDs determined in stages I and II, and sargramostim (GM-CSF) SC once daily on days 1-4, 29-32, 57-60, and 85-88.
Interventions
Given SC
Given intradermally
Eligibility Criteria
You may qualify if:
- Patients must have a histologically confirmed diagnosis of malignancy, with evidence of metastatic disease (evaluable disease is adequate), who have not responded to standard therapy, who have relapsed, or for whom such therapy is not available
- Patients must have a tumor that has been shown to express CEA by immunohistochemical techniques or have had an elevated serum CEA \> 10 at any point during their disease course
- Patients must have an anticipated survival of at least 6 months
- Patients must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent
- Patients must be ambulatory, with an ECOG performance status of 0 or 1, and must be maintaining a reasonable state of nutrition, consistent with weight maintenance
- WBC \>= 3,000/mm\^3
- ANC \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Bilirubin =\< 2 x upper limit of normal
- SGOT and SGPT =\< 4 x upper limit of normal
- All patients should have an initial urine analysis; the initial urine analysis for eligibility is: proteinuria grade 0, hematuria grade 0, and no abnormal sediment; any positive protein including trace values should be evaluated by a 24-hour urine; any other abnormality in the sediment or the presence of hematuria should be evaluated by a nephrologist for evidence of underlying renal pathology; patients may be eligible if the underlying cause of the abnormality is determined to be non-renal
- Normal creatinine is defined by creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 60 ml/min
- At least 6 patients must be HLA-A2 positive for each of cohorts 3, 6, and 7; once the HLA-A2 positive quota of 6 has been met, enrollment to that cohort may close at the discretion of the principal investigator; there are no HLA phenotype restrictions for cohorts 1,2,4, and 5, although phenotyping will be performed on all patients
- Vaccinia-naïve patients may be enrolled to any cohort
- There must be no history of allergy or untoward reaction to prior vaccination with vaccinia virus, for patients on cohorts 4, 5, 6, or 7
- +10 more criteria
You may not qualify if:
- Recent major surgery (within 21 days)
- Frequent vomiting or severe anorexia
- Pregnant or lactating women; this requirement is due to an unacceptable high risk of CEA antibody transfer, which may be potentially harmful to the developing fetus or infant; (NOTE: women and men enrolled in the study are to practice an effective method of birth control for at least six months after their last treatment on protocol)
- 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
- The following therapies are prohibited and may not be administered to patients being treated on this protocol: chemotherapy, hormonal therapy, biologic therapy, and immunotherapy
- Patients must have recovered completely from any reversible toxicity associated with their most 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
- Patients with clinically active brain metastasis, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
- Patients can not have any history (past or present) of allergy to eggs or egg products
- Patients with history of receiving CEA-containing vaccines are excluded from enrollment into any of the 8 actual study cohorts; however, patients with metastatic disease who have progressed (as defined by objective response criteria for solid measurable tumor; tumor marker elevation alone is not sufficient) on a CEA-containing vaccine, may be enrolled to this study as they arise if they meet the patient eligibility criteria, but will be added-in outside of the eight established cohorts, at the currently established safe dose level; additionally, these patients will receive only the rF-CEA(6D)-TRICOM vaccine (possibly along with GM-CSF if cohort 7 is the currently established safe dose level), but otherwise will be treated according to the protocol as any other patient on study; such additional patients will not count toward study accrual, determination of primary immunologic endpoints, or the determination of the MTD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, 20057, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Marshall
Lombardi Comprehensive Cancer Center at Georgetown University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2001
First Posted
February 3, 2004
Study Start
November 1, 2000
Primary Completion
April 1, 2010
Last Updated
May 16, 2013
Record last verified: 2013-05