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A Phase IB Study of Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

A Phase IB Study of Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor


- The vaccines created from the participants melanoma cells are scheduled to be given to
the participants on days 1, 8, 15, 29 and every two weeks after until the supply of
vaccine has run out. The amount of vaccine is dependent on the total amount of cells
yielded when the tumor is processed and treated. It is hoped that participants will
receive at least six vaccines.

- The vaccines will be administered in two injections that will be placed underneath the
participants skin. The two injections will be given at the same place on the body.

- If tumor sample yields enough cells, participants will also receive an injection of
non-transduced irradiated melanoma cells. The purpose of this is to measure the amount
of reaction of the participants immune system occuring created by the vaccine.

- If either the vaccine site or DTH placement site has shown a reaction, a punch-biopsy
will be taken. This will consist of a small piece of skin tissue removed under local
anesthesia.

- With vaccine #5, participants will receive a second DTH injection. Two days after the
vaccine and DTH injection, punch biopsies will be taken of both sites.

- At week 10 of treatment (or earlier if necessary), participants will undergo a chest,
abdomen and pelvic CT scan. The physician may also have participants undergo a brain
MRI if indicated at this time.


Inclusion Criteria:



- Stage III patients must have: A) Histologically documented melanoma B)
Lymphadenopathy of at least 2cm in greatest diameter by physical exam or CT scan in a
region draining a known or suspected primary melanoma or in transit metastatic
disease of at least 2cm in greatest diameter by physical exam or CT in a region
draining a known primary melanoma C) refused, not eligible, or failed adjuvant
therapy with high dose a-interferon D) must be able to have all measurable disease
removed at time of tumor harvest

- Stage IV patients must have histologically documented metastatic melanoma

- ECOG Performance Status 0 or 1

- Estimated life expectancy of 6 months or greater

- 18 years of age or older

- Signed Informed Consent

- Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic
glucocorticoid therapy

- Greater than 6 months since bone marrow or peripheral blood stem cell transplant

Exclusion Criteria:

- Uncontrolled active infection

- Pregnancy or nursing mothers

- Evidence of infection with Human Immunodeficiency Virus, Hepatitis B or C

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the doses of lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete CM-CSF that can be manufactured in stage III melanoma patients.

Outcome Time Frame:

7 years

Safety Issue:

Yes

Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

03-218

NCT ID:

NCT00809588

Start Date:

October 2003

Completion Date:

December 2013

Related Keywords:

  • Melanoma
  • vaccination
  • GM-CSF
  • autologous
  • irradiated
  • Melanoma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617