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Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer


PRIMARY OBJECTIVES:

I. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1
and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node
metastatic tumors.

II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1
and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.

III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by
intra-tumoral injection.

IV. To compare the clinical responses and safety profile of patients with cutaneous tumors
and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM
vaccine.

SECONDARY OBJECTIVES:

I. To establish evidence of host anti-tumor immune reactivity following intra-lesional
vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients
with cutaneous tumors and visceral tumors.

II. To evaluate the quality of life during vaccine administration.

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.


Inclusion Criteria:



- 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

- Performance status - ECOG 0-1

- More than 3 months

- Absolute granulocyte count at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- No bleeding diathesis

- 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

- Creatinine no greater than 2.0 mg/dL

- No renal insufficiency

- No chronic obstructive pulmonary disorder

- 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

- 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

- More than 8 weeks since prior immunotherapy and recovered

- More than 4 weeks since prior chemotherapy and recovered

- At least 4 weeks since prior systemic corticosteroids

- No concurrent corticosteroids

- More than 2 weeks since prior radiotherapy and recovered

- No evidence of bone marrow toxicity from prior radiotherapy

- More than 4 weeks since prior surgery and recovered

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentages of the DLTEs

Outcome Description:

Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Howard Kaufman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02455

NCT ID:

NCT00030693

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific

Name

Location

Mount Sinai Medical CenterNew York, New York  10029