# Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma

> **NCT00091104** · PHASE1 · COMPLETED · sponsor: **National Institutes of Health Clinical Center (CC)** · enrollment: 136 (estimated)

## Conditions studied

- Melanoma (Skin)

## Interventions

- **BIOLOGICAL:** MART-1:27-35 peptide vaccine
- **BIOLOGICAL:** aldesleukin
- **BIOLOGICAL:** filgrastim
- **BIOLOGICAL:** incomplete Freund's adjuvant
- **BIOLOGICAL:** therapeutic autologous lymphocytes
- **BIOLOGICAL:** therapeutic tumor infiltrating lymphocytes
- **DRUG:** cyclophosphamide
- **DRUG:** fludarabine phosphate
- **PROCEDURE:** autologous hematopoietic stem cell transplantation
- **PROCEDURE:** in vitro-treated peripheral blood stem cell transplantation
- **RADIATION:** total-body irradiation

## Key facts

- **NCT ID:** NCT00091104
- **Lead sponsor:** National Institutes of Health Clinical Center (CC)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2004-07
- **Primary completion:** 2010-08
- **Final completion:** 2010-10
- **Target enrollment:** 136 (ESTIMATED)
- **Last updated:** 2012-03-15

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00091104

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00091104, "Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT00091104. Licensed CC0.

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