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Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Stage IV Melanoma

NCT00438984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2012-03-16

No results posted yet for this study

Summary

RATIONALE: Biological therapies, such as therapeutic autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor cells. Giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin may be an effective treatment for melanoma.

PURPOSE: This phase I trial is studying the side effects of giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin in treating patients with stage IV melanoma

Conditions

  • Recurrent Melanoma
  • Stage IV Melanoma

Interventions

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

therapeutic autologous lymphocytes

Given IV

BIOLOGICAL

aldesleukin

Given IV or SC

OTHER

immunohistochemistry staining method

Correlative studies

PROCEDURE

biopsy

Optional correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

immunologic technique

Correlative studies

GENETIC

polymerase chain reaction

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    lead OTHER

Principal Investigators

  • Cassian Yee · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2011-01-31
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00438984 on ClinicalTrials.gov