Last updated on March 2019

In Situ Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol


Brief description of study

The purpose of this study is to evaluate the safety of sequential intratumoral (IT) plus intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC, Hiltonol) for treatment of study subjects with advanced accessible solid tumors

Detailed Study Description

Hiltonol will be administered by intratumoral injection into injectable cutaneous, subcutaneous and nodal tumors with or without image ultra sound guidance. Visceral organ metastases will not be injected.

Cycle 1 (weeks 1-13): One readily accessible tumor site (e.g., mucosal, SC or submucosal, or cutaneous lymph node) will be targeted for injection. The patient will remain in clinic for monitoring for 1 hour following each of the first two IT injections. Any patient who has a significant reaction to an IT injection will be observed for 2 hours following all subsequent IT injections. The target lesion will be biopsied within 7 days prior to the first injection. If an additional lesion is easily accessible this will also be biopsied.

Study subjects will receive 3 Intra-tumoral (IT) injections of 1.0 mg (0.5 ml) poly-ICLC into the same lesion on Cycle 1 Week 1 D1, D3, and D5. A dosing range of 7 days is allowed. Cycle weeks may be shifted as a result of treatment adjustments. One readily accessible tumor site (e.g. cutaneous, mucosal, SC or submucosal) will be targeted for each cycle of intra-tumoral injections of poly-ICLC. Study subjects will remain in clinic for monitoring for 1 hour after each of the first two IT injections. If any patient has a significant reaction to the IT injection he or she will remain in clinic for 2-hour post injection observations for all subsequent IT injections. All 3 injections should be given before Week 2 unless there is an adjustment to a subject's treatment schedule. No more than one injection may be given on a single day. Treatment adjustments may be the result of unusual circumstances such as conditions impeding travel, toxicities, a subject's health status requiring medical intervention outside the purview of study treatment, or the like.

On weeks 2-13 study subjects will then receive booster injections of 1.0 mg (0.5 ml) IM Poly-ICLC twice weekly at an interval of 48-72 hours between the two injections. These injections may be administered either in the clinic or at home by the study subjects or the study subjects' person of choice (e.g., family member, friend). Study subjects who elect the at home administration option will be given a set of written instructions to follow, and a diary sheet that they are required to maintain showing when the dates and times injections were given and the injection sites (extremities). For consistency, study subjects will be instructed to allow an interval of 48-72 hours between the two injections. IM injections will be performed using standard technique. Injection site may be rotated based on study subjects' and investigator preference and will be recorded in the diary. The study nurse will train the study subjects, or the study subjects' person of choice, on how to inject IM Poly-ICLC for those study subjects who want the option of home treatment. The first injection will be administered in clinic under the supervision of study clinical staff and the patient will be monitored for at least 30 minutes after the first IM injection including a determination of blood pressure, heart rate, and respiratory rate before and after injection.

The investigational pharmacy will follow its standard operating procedures (SOPs) when dispensing the study drug for distribution to the study subjects. Study subjects will be instructed to select the day for that week's first administration of Poly-ICLC and to administer (or have their person of choice administer) the second injection between 2 and 3 days following the first injection. The clinical staff will provide study subjects with a sufficient supply of Poly-ICLC, sterile syringes with needles and alcohol swabs for this purpose.

The study subjects will also be provided with a diary wherein the date, time and injection site of the study drug is to be noted as well as comments on any side effects. The diary will be reviewed by the clinic staff with the study subject at clinic visits and collected from the study subject at the following study visit. Study subjects and/or their person of choice will be instructed to allow a 48-72 hour interval between the two injections, and that it is anticipated that the two injections will be given during the course of each 7 day period starting on Week 3 through week 13. Study subjects will be given the option to receive IM injections in the clinic if they prefer.

Cycle 2 (weeks 14-26): One readily accessible tumor site (e.g. cutaneous, mucosal, SC or submucosal) will be targeted for injection. Study subjects will receive 3 Intra-tumoral (IT) injections of 1.0 mg (0.5 ml) poly-ICLC into the same lesion on Week 14 D1, D3, and D5. A dosing range of 7 days is allowed. Cycle weeks may be shifted as a result of treatment adjustments. No more than one injection is given on the same day and all injections are completed before Week 15 (or week 16 if study treatments are adjusted). A second biopsy of target lesion will be performed prior to, or within 7 days of the last IT injection in cycle 2. If there is another easily accessible lesion, a non-targeted/non-injected index lesion will also be biopsied within 7 days following the last IT injection of cycle 2. A third biopsy will be taken at week 26.

The second cycle may target the same or a different metastatic site at the discretion of the investigator, but only one lesion will be injected for a given cycle.

In cycle 2, IM injections will be given biweekly on weeks 15-25. The first IM injection for cycle 2 may be given by the study subjects or study subjects' person of choice at home; however, it may be given in the clinic at the study subject's preference.

Tumor Assessment: During week 26, tumor assessments will be performed

Follow up Period:

After completion of study treatment, study subjects may be contacted by telephone twice yearly for up to 36 months to inquire on their health status (e.g., alive, remission, progressive disease, on new cancer treatment). Study subjects with an initial tumor response but then long-term recurrence during the follow up period may be offered additional cycles of treatment depending on the study subject's health status, costs and/or drug availability.

Clinical Study Identifier: NCT02423863

Find a site near you

Start Over

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.