Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, may be used to prepare the body for other treatments, such as cellular adoptive immunotherapy. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. Giving cyclophosphamide together with fludarabine followed by biological therapy may be an effective treatment for metastatic melanoma.

PURPOSE: This phase I trial is studying the side effects of giving cyclophosphamide together with fludarabine followed by cellular adoptive immunotherapy, and vaccine therapy in treating patients with metastatic melanoma.

Detailed Description

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OBJECTIVES:

* Determine the magnitude and duration of the expansion of antigen-specific T-cells present in post-vaccination peripheral blood mononuclear cells and reinfused after immunosuppression in patients with metastatic melanoma.
* Characterize the T-cell subsets (phenotype, function, T-cell receptor repertoire) in these patients.
* Determine the tumor response in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label dose-finding study. Patients undergo leukapheresis to collect whole peripheral blood mononuclear cells (PBMC). Patients are then assigned to 1 of 3 treatment groups.

* Group 1 (closed to accrual as of 5/8/2007): Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -3. Patients undergo autologous PBMC infusion on day 0. Patients also receive vaccination comprising Melan-A vaccine emulsified in incomplete Freund's adjuvant (IFA) subcutaneously (SC) once every 3 weeks beginning on day 0.
* Group 2 (closed to accrual as of 8/15/2007): Patients receive cyclophosphamide IV at a higher dose than in group 1 on days -7 and -6 and fludarabine IV on days -5 to -3. Patients also receive an autologous PBMC infusion and Melan-A vaccine emulsified in IFA as in group 1.
* Group 3: Patients receive cyclophosphamide IV at 30 mg/kg on days -7 and -6. Patients also receive fludarabine 30 mg/m2 IV on days -5 to -3, autologous PBMC infusion on day 0,and Melan-A vaccine emulsified in IFA and IMP321. The first 3 patients receive 25 micrograms of IMP321, in the absence of severe 3 or 4 toxicity, the dose will be escalated to IMP321 250 micrograms.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Conditions

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Melanoma (Skin)

Keywords

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stage IV melanoma recurrent melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

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Inclusion Criteria

PATIENT CHARACTERISTICS:

* Performance status 0-2
* Whole blood counts normal
* Pulmonary status normal
* Transaminases \< 1.5 times upper limit of normal (ULN)
* Gamma-glutamyl-transferase \< 1.5 times ULN
* Bilirubin normal
* Creatinine clearance \> 70 mL/min
* No major uncontrolled heart disease
* No arterial hypertension

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior chemotherapy, biologic therapy, radiotherapy, and/or surgery allowed

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Serge Leyvraz

Chef de Service

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Serge Leyvraz, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois

Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Lymphodepletion, vaccine, IMP321 adjuvant

Melan-A VLP vaccine, IMP321 adjuvant

adoptive immunotherapy

therapeutic autologous lymphocytes

cyclophosphamide

fludarabine phosphate

Interventions

Melan-A VLP vaccine, IMP321 adjuvant

adoptive immunotherapy

therapeutic autologous lymphocytes