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Home > "V" Clinical Trials Conditions > Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer  Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
For Condition: Endocrine Cancer,female reproductive cancer,Breast Cancer,Gastrointestinal Cancer,Head and Neck Cancer
Status: Suspended
Sponsor(s): Fox Chase Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer.
Details: OBJECTIVES: - Determine the toxicity of recombinant fowlpox-CEA-TRICOM vaccine with or without sargramostim (GM-CSF) or recombinant fowlpox-GM-CSF in patients with advanced or metastatic CEA-expressing adenocarcinomas. - Determine the CEA-specific T-cell precursor frequency in patients treated with these regimens. - Assess the immunogenicity of GM-CSF in patients treated with these regimens. - Determine the inflammatory response and cytokine expression at the vaccination site in these patients 48 hours after vaccination. - Correlate telomere length of leukocytes with prior cytotoxic therapies and immunologic response in patients treated with these regimens. OUTLINE: This is a dose-escalation study. The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine (fCEA-TRI) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients or 3 of 12 patients experience dose-limiting toxicity. fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter (beginning on day 56) in the absence of disease progression or unacceptable toxicity. The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim (GM-CSF). GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days. The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF (rF-GM-CSF). rF-GM-CSF is administered in the same manner as GM-CSF. Patients are followed every month for 4 months. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1.2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8 weeks - Advanced or metastatic disease - Recurrent or unresectable disease - Microscopic metastatic disease confirmed by surgical exploration allowed - CEA expression by immunohistochemistry OR - Circulating CEA greater than 5 ng/mL - HLA phenotyping required - HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation - No clinically symptomatic brain metastases - Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST and ALT less than 3 times ULN - PT and PTT less than 1.5 times ULN (unless therapeutically anticoagulated) Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min - Proteinuria or hematuria less than +2 on urinalysis* OR - Urine protein less than 1,000 mg/24-hour collection, if proteinuria greater than +1 NOTE: Proteinuria of +2 allowed provided etiology is non-renal Gastrointestinal: - No frequent vomiting or severe anorexia - No more than 10% weight loss within the past 3 months - No inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis Neurologic: - No uncontrolled seizure disorders - No encephalitis - No multiple sclerosis Immunologic: - No allergy to eggs - No HIV-associated opportunistic infection - No autoimmune diseases, including the following: - Systemic lupus erythematosus - Sjögren's syndrome - Scleroderma - Myasthenia gravis - Goodpasture syndrome - Addison's disease - Hashimoto's thyroiditis - Graves' disease - Antinuclear antibody positive status allowed if no evidence of an autoimmune disease Other: - No direct contact of vaccination site with the following persons for at least 72 hours after each vaccination: - Children under 1 year of age - Pregnant women - Individuals with eczema or other open skin condition - Immunocompromised individuals - No other concurrent serious medical illness that would preclude study entry - No other malignancy within the past 2 years except excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for at least 1 month before (female patients only), during, and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior CEA-directed active immunotherapy - Prior CEA-directed antibody therapy allowed - At least 4 weeks since prior immunotherapy and recovered - No other concurrent antineoplastic biologic therapy or immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No concurrent antineoplastic chemotherapy Endocrine therapy: - See Disease Characteristics - No concurrent antineoplastic hormonal therapy - No concurrent systemic steroids (inhaled steroids allowed) - Concurrent systemic mineralocorticoids (e.g., megestrol for appetite stimulation or fludrocortisone) allowed - Concurrent birth control pills allowed Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 50% of all nodal groups Surgery: - See Disease Characteristics - Recovered from prior surgery - No prior splenectomy Other: - Concurrent non-steroidal anti-inflammatory drugs allowed - No other concurrent anti-cancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MargaretMehren, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000069093; NCI-1133,FCCC-01016
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028496
Other Endocrine Cancer Studies:
1. Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
2. Octreotide in Preventing Diarrhea in Patients Who Are Undergoing Radiation Therapy to the Pelvis
3. Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
4. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
5. BCX-1777 in Treating Patients With Refractory Cancer
Related Studies:
Other Endocrine Cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
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