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Phase I Trial of a Dendritic Cell Vaccine for Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Phase I Trial of a Dendritic Cell Vaccine for Melanoma


OBJECTIVES:

I. Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II
dose, and rate of sensitization of T cells at each dose level in patients with melanoma
receiving dendritic cell vaccine.

II. Determine the overall (complete and partial) response rate, duration of response, and
optimal route of administration in this patient population.

OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment
arms.

All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell
fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5
patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as
the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity.
Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue.
Treatment repeats every 2 weeks for a total of 4 doses.

Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into
3 different peptide pulsed pools administered over 30 minutes.

Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine
subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose,
patients receive 3 different peptide pulsed pools, each administered at a separate site. At
the higher doses, patients receive 3 injections further subdivided into 6 and administered
at 6 distinct sites.

Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph
nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose,
patients receive 3 different peptide pulsed pools, each administered into a different node.
At the higher dose, patients receive 3 injections further subdivided into 6 and administered
at 6 distinct sites.

Patients are followed at 2 weeks and then monthly for 3 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

-Histologically confirmed stage IV melanoma Must be MHC Class I HLA-A2.1

PATIENT CHARACTERISTICS:

- Age: Over 18

- Performance status: ECOG 0-1

- Life expectancy: At least 2 months

- Platelet count at least 100,000/mm3

- INR no greater than 1.5 mg/dL

- No coagulopathies including thrombocytopenia

- Partial thromboplastin time no greater than 50 seconds

- No major cardiac illness

- No major respiratory illness

- No active systemic infection or other illness

- No peripheral vascular disease

- Not pregnant or nursing

- Effective contraception required of all fertile patients during and for one month
after completion of treatment

PRIOR CONCURRENT THERAPY:

- At least 30 days since prior immunotherapy

- No concurrent immunotherapy

- At least 30 days since prior chemotherapy

- No concurrent chemotherapy

- At least 30 days since prior radiotherapy

- No concurrent radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Brian J. Czerniecki, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02292

NCT ID:

NCT00003665

Start Date:

April 1999

Completion Date:

November 2002

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104