Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	CPMC-IRB-14535 AECM-01-122, NCI-3351, CPMC-IRB-01-122, NCT00030693, 3351

Objectives

1. 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.
2. Compare the feasibility of intratumoral administration of these vaccines in patients with visceral metastatic solid tumors.
3. Compare the clinical toxicity of these vaccines in these patients.
4. Determine the optimal dose of these vaccines in these patients.
5. Compare the clinical response of patients treated with these vaccines.
6. Compare the safety profiles of these vaccines in these patients.
7. Determine the quality of life of patients treated with these vaccines.
8. Determine the anti-tumor immune reactivity in patients treated with these vaccines.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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.

Outcomes

Safety by CTC every 2 weeks

Immune response as assessed by ELISPOT assay at 2 weeks following course 3 and at 3 months
Objective response rate by RECIST at 2 weeks following course 3 and at 3 months

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Howard Kaufman, MD, Protocol chair(Contact information may not be current)		Ph: 212-342-6042 Email: hlk2003@columbia.edu

Registry Information
Official Title		Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
Trial Start Date		2002-01-28
Registered in ClinicalTrials.gov		NCT00030693
Date Submitted to PDQ		2001-12-18
Information Last Verified		2006-08-15
NCI Grant/Contract Number		CA13330

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