Vaccine Therapy in Treating Patients With Metastatic Solid Tumors - Full Text View

Sponsors and Collaborators:	Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030693

Purpose

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	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: recombinant fowlpox-B7.1 vaccine Drug: recombinant fowlpox-TRICOM vaccine	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Metronidazole Metronidazole hydrochloride Metronidazole phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety by CTC every 2 weeks [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immune response as assessed by ELISPOT assay at 2 weeks following course 3 and at 3 months [ Designated as safety issue: No ]
Objective response rate by RECIST at 2 weeks following course 3 and at 3 months [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	January 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030693

Locations

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

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Howard L. Kaufman, MD

Herbert Irving Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069189, CPMC-IRB-14535, AECM-01-122, NCI-3351, CPMC-IRB-01-122
Study First Received:	February 14, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00030693
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Metronidazole
Neoplasm Metastasis

ClinicalTrials.gov processed this record on January 15, 2009