Clinical Trial Details
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NCT02423863 : In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol®
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Histologically confirmed diagnosis of one of the following:

- Melanoma

- Squamous head and neck cancer

- Sarcoma

- Non-Melanoma skin cancers

2. Sarcoma Patients must be 14 years of age or older. All other patients must be 18 years
of age or older.

3. Unresectable disease. Patients with resectable disease may be enrolled after having
refused surgery after a documented consultation with a surgeon.

4. Disease has progressed through at least one systemic therapy or through local
irradiation within the preceding 6 months.

5. Radiologically or visually measurable recurrent or metastatic disease that is
measurable and at least 10mm in longest dimension.

6. At least one accessible primary or metastatic tumor site that can be readily injected
IT with poly-ICLC with or without ultrasound guidance. This lesion can be superficial
cutaneous, subcutaneous or within a readily accessible lymph node and must measure at
least 10 mm in longest dimension.

7. The tumor site selected for injection cannot have been irradiated within 8 weeks of
Cycle 1 Day 1 (C1D1)

8. Eastern Cooperative Oncology Group (ECOG) performance status of = 2.

9. Acceptable hematologic, renal and liver function as follows:

- Absolute neutrophil count > 1000/mm3,

- Platelets > 50,000/mm3,

- Creatinine = 2.5 mg/dl,

- Total bilirubin = 1.5mg/dl,

- Transaminases = 2 times above the upper limits of the institutional normal, -
INR<2 (international normalized ratio) if off of anticoagulation. Patients on
anticoagulation therapy with an INR>2 may be enrolled at the discretion of the
investigator if they have not had any episodes of severe hemorrhage and if the
site to be injected is not located in the oropharynx or another area where
achieving homeostasis would be complicated by local anatomy.

10. Patients must be able to provide informed consent.

11. Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception. Contraception must be
continued for at least 2 months following the last dose of poly-ICLC. Women of
childbearing potential must have a negative pregnancy test. While animal reproductive
studies have been negative, the simulated viral infection and anti-proliferative
activity of this experimental drug may theoretically affect the developing fetus or
nursing infant.

Exclusion Criteria:

1. Serious concurrent infection or medical illness, which would jeopardize the ability of
the patient to receive the treatment outlined in this protocol with reasonable safety.

2. Bulky intracranial metastatic disease with shift of midline structures or progressive
brain metastasis such that ongoing therapy for these brain metastasis is required at
the time of enrollment.

3. In the opinion of the local PI: Head and neck cancer patients with airway tumor
recurrence that may compromise breathing or swallowing if inflammation or edema is
transiently aggravated by Hiltonol injection. Head and neck cancer patients with tumor
invading major blood vessels for whom there may be a risk of blockage or bleeding if
inflammation or edema is transiently increased by Hiltonol injections.

4. AIDS defined as a CD4 (cluster of differentiation 4) count less then 200 in the
context of HIV sero-positivity or chronically is taking immunosuppressive medication
such as steroids or transplant related medications.

5. Life expectancy of less than 6 months in the judgment of the study physician.

6. Persistent toxicity from recent therapy that has not sufficiently resolved in the
judgment of the study physician.

7. History of active immunotherapy in the previous month.
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