NCT00006233

Brief Summary

RATIONALE: Drugs used in chemotherapy such as fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells can reject the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, total-body irradiation, peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have stage IV melanoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

First QC Date

September 11, 2000

Last Update Submit

November 28, 2011

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL
cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Partial response, minor response, or stable disease after no more than 2 regimens of chemotherapy, immunotherapy, or chemoimmunotherapy * Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging * HLA genotypically identical sibling donor available * Not an identical twin * Age 12 to 74 * No ocular melanoma * No active or untreated brain metastases or transmural gastrointestinal metastases PATIENT CHARACTERISTICS: Age: * 18 to 64 Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT and SGPT less than 2 times ULN Renal: * Creatinine clearance at least 40 mL/min Cardiovascular: * LVEF at least 40% if history of congestive heart failure * No uncontrolled hypertension Pulmonary: * DLCO at least 50% of predicted * No continuous supplementary oxygen Other: * Not pregnant * Fertile patients must use effective contraception during and for 1 year after study participation * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No concurrent growth factors during mycophenolate mofetil administration Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cyclosporinefludarabine phosphateMycophenolic AcidPeripheral Blood Stem Cell TransplantationRadiotherapy

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

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • John A. Thompson, MD

    Seattle Cancer Care Alliance

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

January 1, 2000

Study Completion

December 1, 2003

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(1)