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NCT00006385 · ClinicalTrials.gov registry record · Phase 2

Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma

A Phase 2 study of Melanoma (Skin), sponsored by Eastern Cooperative Oncology Group.

Completed
Registry status
Phase 2
Development phase
20
Study locations

NCT00006385: Completed Phase 2 study of Melanoma (Skin), sponsored by Eastern Cooperative Oncology Group.

NCT00006385 is a Phase 2 study of Melanoma (Skin) that has completed, run by Eastern Cooperative Oncology Group. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00006385, a Phase 2 study of Melanoma (Skin), has completed, sponsored by Eastern Cooperative Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
20
Study locations

Study Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or without biological therapy for melanoma. PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without biological therapy in treating patients who have metastatic melanoma.

Conditions Studied

Melanoma (Skin)

Interventions

  • BIOLOGICAL recombinant interferon alfa
  • BIOLOGICAL sargramostim
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL gp100 antigen
  • BIOLOGICAL MART-1 antigen

Study Locations (20)

Illinois

  • Veterans Affairs Medical Center - Lakeside Chicago - Chicago
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University - Chicago
  • CCOP - Evanston - Evanston
  • CCOP - Carle Cancer Center - Urbana

Georgia

  • Emory University Hospital - Atlanta - Atlanta
  • Veterans Affairs Medical Center - Atlanta (Decatur) - Decatur

Indiana

  • Indiana University Cancer Center - Indianapolis
  • Veterans Affairs Medical Center - Indianapolis (Roudebush) - Indianapolis

Massachusetts

  • Tuft-New England Medical Center - Boston
  • Beth Israel Deaconess Medical Center - Boston

New Jersey

  • CCOP - Northern New Jersey - Hackensack
  • Cancer Institute of New Jersey - New Brunswick

Arizona

  • CCOP - Scottsdale Oncology Program - Scottsdale

Iowa

  • CCOP - Iowa Oncology Research Association - Des Moines

Kansas

  • CCOP - Wichita - Wichita

Trial Details

FieldValue
Start Date 2000-09
Phase Phase 2
Eastern Cooperative Oncology Group

141 total trials

What the finished NCT00006385 record still lists

NCT00006385 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which recombinant interferon alfa is the first listed.

NCT00006385 names 20 study sites across 13 states, led by Illinois, Georgia, Indiana.

Frequently Asked Questions

What is clinical trial NCT00006385 about?

NCT00006385 is a clinical study titled "Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma". RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as sargramostim and interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if vaccine therapy if more effective with or wit...

What is the current status of trial NCT00006385?

This trial is currently completed. It is a Phase 2 study. The study started on 2000-09.

What conditions does trial NCT00006385 study?

This clinical trial studies the following conditions: Melanoma (Skin).

What interventions are being tested in trial NCT00006385?

The interventions under investigation include: recombinant interferon alfa (BIOLOGICAL), sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), gp100 antigen (BIOLOGICAL), MART-1 antigen (BIOLOGICAL).

Who is sponsoring clinical trial NCT00006385?

This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00006385 being conducted?

This trial has 20 study locations across Arizona, Georgia, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00006385, the US trial registry maintained by the National Library of Medicine. NCT00006385 (unsized enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.