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Phase I/II Trial of the Safety, Immunogenicity, and Efficacy of Autologous Dendritic Cells Transduced With Adenoviruses Encoding the MART-1 and gp100 Melanoma Antigens Administered With or Without Low Dose Recombinant Interleukin-2 (rIL-2) in Patients With Stage IV Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

Phase I/II Trial of the Safety, Immunogenicity, and Efficacy of Autologous Dendritic Cells Transduced With Adenoviruses Encoding the MART-1 and gp100 Melanoma Antigens Administered With or Without Low Dose Recombinant Interleukin-2 (rIL-2) in Patients With Stage IV Melanoma


OBJECTIVES: I. Evaluate the safety, dose-limiting toxicity, and maximum tolerated dose of
autologous dendritic cells transduced with adenoviruses encoding the MART-1 and gp100
melanoma antigens with or without interleukin-2 in patients with stage III or IV melanoma.
II. Evaluate the cellular response and efficacy of these regimens in this patient
population.

OUTLINE: This is a dose-escalation study. Patients are sequentially assigned to one of three
dose levels. Patients receive modified autologous dendritic cells subcutaneously on day 1
with or without interleukin-2 IV on days 4-19. Treatment continues every 21 days for a total
of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of modified dendritic cells with or without interleukin-2
until the maximum tolerated dose (MTD) for each regimen is reached. The MTD is defined as
the dose below that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study within 1
year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV metastatic melanoma
Unresectable disease for which no other therapy exists Measurable or evaluable disease by
clinical or radiographic evaluation Metastatic tumor tissue expressing both gp100 and
MART-1 No uncontrolled or progressive CNS involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No
clinically significant hematologic disorder Hepatic: Bilirubin less than 2.0 mg/dL No
clinically significant hepatic disease Hepatitis B surface antigen negative Renal:
Creatinine less than 2.0 mg/dL No clinically significant renal disease Cardiovascular: No
clinically significant cardiac disease Other: Not pregnant or nursing Fertile patients
must use effective contraception Negative pregnancy test HIV-1 and HIV-2 negative HTLV-1
negative No significant psychiatric disorder that would prevent compliance No underlying
condition that would preclude study therapy No autoimmune disease or other major immune
system illness No active infection requiring parenteral antibiotic therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy with vaccines directed
at MART-1 or gp100 melanoma antigens Prior interleukin-2 or interferon therapy allowed
Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent
chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered Surgery: At least 4 weeks since prior surgery (except study
biopsies) and recovered Other: At least 4 weeks since prior experimental therapy and
recovered At least 4 weeks since prior immunosuppressive drugs and recovered No other
concurrent experimental therapy or anti-cancer drugs No concurrent immunosuppressive
therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Amy E. Bock

Investigator Role:

Study Chair

Investigator Affiliation:

Genzyme

Authority:

United States: Federal Government

Study ID:

CDR0000067245

NCT ID:

NCT00004025

Start Date:

March 1999

Completion Date:

Related Keywords:

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

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
U.S. OncologyHouston, Texas  77060