NCT00004025

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens may make the body build an immune response to tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for stage III or stage IV melanoma. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be surgically removed.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4 years until next milestone

First Posted

Study publicly available on registry

October 29, 2003

Completed
Last Updated

January 6, 2014

Status Verified

July 1, 2002

First QC Date

November 1, 1999

Last Update Submit

January 3, 2014

Conditions

Melanoma (Skin)

Keywords

stage III melanomastage IV melanomarecurrent melanoma

Interventions

aldesleukinBIOLOGICAL
dendritic cell-gp100-MART-1 antigen vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

U.S. Oncology

Houston, Texas, 77060, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Amy E. Bock

    Genzyme, a Sanofi Company

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

October 29, 2003

Study Start

March 1, 1999

Last Updated

January 6, 2014

Record last verified: 2002-07

Locations

US(2)