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Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100


OBJECTIVES:

- Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of
immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens
with or without interleukin-2 in patients with metastatic melanoma.

OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100
antigens.

Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens,
either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some
patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours
after immunization.

Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells
with or without interleukin-2. One cohort may expand to 15 patients to determine the
accuracy of immunologic response to the vaccine.

One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4
weeks for 2 courses. Patients with stable disease or who achieve minor, mixed, or partial
response may be retreated.

Patients with stable or responding disease undergo a second course of vaccination. Patients
who completed treatment with vaccine alone and have stable disease, progressive disease,
disease progression after a response, or a partial response with no further improvement may
receive 2 additional courses.

PROJECTED ACCRUAL: A total of 10-42 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma that has failed standard effective
therapy

- Measurable or evaluable disease

- HLA-A2 positive

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 8.0 g/dL

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- AST/ALT less than 4 times upper limit of normal

- Negative hepatitis B surface antigen

- No coagulation disorder

Renal:

- Creatinine no greater than 1.6 mg/dL OR

- Creatinine clearance greater than 75 mL/min

Cardiovascular:

- No major cardiovascular disease

Pulmonary:

- No major respiratory disease

Other:

- No major immunological disease

- No penicillin allergy

- HIV negative

- No active systemic infection

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- At least 4 weeks since prior steroid therapy and recovered

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 4 weeks since any other prior therapy and recovered

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James C. Yang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000065234

NCT ID:

NCT00019214

Start Date:

April 1997

Completion Date:

July 2006

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • Melanoma

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182