RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors.

PURPOSE: Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: fowlpox-TRICOM vaccine  Drug: rF-B7.1 vaccine  Procedure: biological response modifier therapy  Procedure: recombinant viral vaccine  Procedure: vaccine therapy	Phase I

Further Study Details: 

OBJECTIVES:

• Compare the feasibility of intratumoral administration of rF-B7.1 vaccine vs recombinant fowlpox-TRICOM vaccine in patients with cutaneous, subcutaneous, or lymph node metastatic solid tumors.
• Compare the feasibility of intratumoral administration of these vaccines in patients with visceral metastatic solid tumors.
• Compare the clinical toxicity of these vaccines in these patients.
• Determine the optimal dose of these vaccines in these patients.
• Compare the clinical response of patients treated with these vaccines.
• Compare the safety profiles of these vaccines in these patients.
• Determine the quality of life of patients treated with these vaccines.
• Determine the anti-tumor immune reactivity in patients treated with these vaccines.

OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive rF-B7.1 vaccine intratumorally on day 1.
• Arm II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1. Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses.

Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment.

Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients (21 per treatment arm; 12 in the cutaneous stratum and 30 in the visceral stratum) will be accrued for this study within 1-2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic unresectable solid tumors
• Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
• No standard therapy available
• At least 1 unidimensionally measurable lesion
• At least 20 mm for visceral lesions
• At least 10 mm for cutaneous, subcutaneous, and nodal lesions
• No untreated or edematous metastatic brain lesions
• At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
• No ascites or pleural effusions
• No leptomeningeal disease

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• More than 3 months

Hematopoietic:

• Absolute granulocyte count at least 3,000/mm^3
• Platelet count at least 100,000/mm^3
• No bleeding diathesis

Hepatic:

• Bilirubin no greater than 1.5 mg/dL*
• SGOT/SGPT no greater than 2 times upper limit of normal (ULN)*
• Alkaline phosphatase no greater than 2 times ULN*
• No elevated PT or PTT
• No cirrhosis
• No active hepatitis
• No hepatic insufficiency NOTE: * Unless due to metastases

Renal:

• Creatinine no greater than 2.0 mg/dL
• No renal insufficiency

Pulmonary:

• No chronic obstructive pulmonary disorder

Immunologic:

• No active autoimmune disorders
• No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis)
• No significant allergy or hypersensitivity to eggs

Other:

• No active seizure disorder
• No active or chronic infections
• No other significant medical disease that would preclude study participation
• No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• More than 8 weeks since prior immunotherapy and recovered

Chemotherapy:

• More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

• At least 4 weeks since prior systemic corticosteroids
• No concurrent corticosteroids

Radiotherapy:

• See Disease Characteristics
• More than 2 weeks since prior radiotherapy and recovered
• No evidence of bone marrow toxicity from prior radiotherapy

Surgery:

• See Disease Characteristics
• More than 4 weeks since prior surgery and recovered

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

Howard L. Kaufman, MD,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000069189; CPMC-IRB-14535; AECM-01-122; NCI-3351; CPMC-IRB-01-122; NCT00030693
Record last reviewed:  March 2003
Last Updated:  December 6, 2004
Record first received:  February 14, 2002
ClinicalTrials.gov Identifier:  NCT00030693
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08