RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients
who have advanced cancer.
OBJECTIVES: I. Determine the safety, tolerance, and maximum tolerated dose of TG4010 in
patients with MUC1 positive advanced cancer. II. Determine the biological and immunological
effects of this regimen in this patient population.
OUTLINE: This is a dose escalation study. Patients receive TG4010 IM weekly for 4 weeks,
every other week for 8 weeks, and then every 4 weeks. Treatment continues every 4 weeks in
the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive
escalating doses of TG4010 until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 3 of 6 patients experience treatment related
grade 3 toxicity. If any patient experiences grade 4 toxicity, the prior dose level is
considered the MTD.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 months.
DISEASE CHARACTERISTICS: Histologically confirmed cancer not amenable to cure by any
standard modality and not suitable for accepted palliative care with chemotherapy,
immunotherapy, or hormonal therapy Histologically confirmed MUC1 antigen expression No
uncontrolled or symptomatic CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,000/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of
normal (ULN) Transaminase no greater than 3 times ULN (unless attributable to metastatic
disease) Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for 3
months after study HIV negative No active systemic infections No other serious concurrent
systemic medical disorders that would preclude study compliance No history of, or
immediate household contact with, eczema, exfoliative skin disorders, pregnant women,
children under 3 years of age, or other immunocompromise offering an increased risk for
disseminated vaccinia infection
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for
nitrosamines and mitomycin) No concurrent chemotherapy Endocrine therapy: See Disease
Characteristics No concurrent systemic corticosteroid therapy No concurrent hormonal
therapy Radiotherapy: See Disease Characteristics At least 3 weeks since prior
radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: No
concurrent immunosuppressive drugs No other concurrent experimental protocol No other
concurrent antitumor therapy