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Vaccine Therapy in Treating Patients With Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003665
Recruitment Status : Completed
First Posted : February 9, 2004
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: dendritic cell-MART-1 peptide vaccine Biological: gp100 antigen Biological: therapeutic tumor infiltrating lymphocytes Biological: tyrosinase peptide Phase 1

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of a Dendritic Cell Vaccine for Melanoma
Study Start Date : April 1999
Actual Primary Completion Date : October 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: dendritic cell-MART-1 peptide vaccine
Biological: gp100 antigen
Biological: therapeutic tumor infiltrating lymphocytes
Biological: tyrosinase peptide
Experimental: 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.
 Biological: dendritic cell-MART-1 peptide vaccine
Biological: gp100 antigen
Biological: therapeutic tumor infiltrating lymphocytes
Biological: tyrosinase peptide
Experimental: 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.
 Biological: dendritic cell-MART-1 peptide vaccine
Biological: gp100 antigen
Biological: therapeutic tumor infiltrating lymphocytes
Biological: tyrosinase peptide


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003665


Locations
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United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: Brian J. Czerniecki, MD, PhD Abramson Cancer Center at Penn Medicine
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003665    
Other Study ID Numbers: NCI-2012-02292
UPCC-4697
NCI-T98-0033
CDR0000066759 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 9, 2004    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013
Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas