Vaccine Therapy Following Therapeutic Autologous Lymphocytes and Cyclophosphamide in Treating 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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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This phase I trial studies the side effects and best dose of autologous T-antigen-presenting cells (T-APC) vaccine following therapeutic autologous lymphocytes (CTL) and cyclophosphamide in treating patients with metastatic melanoma. Aldesleukin may stimulate lymphocytes, such as CTL, to kill melanoma cells. Treating lymphocytes with aldesleukin in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Vaccines made from melanoma antigen may help the body build an effective immune response to kill tumor cells and may boost the effect of the CTL. 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. Giving T-APC vaccine after CTL and cyclophosphamide may be an effective treatment for melanoma

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Detailed Description

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PRIMARY OBJECTIVES:

I. Assess the safety and toxicity of T-APC vaccination following adoptive T cell therapy.

II. Evaluate the functional and numeric in vivo persistence of adoptively transferred cytotoxic t lymphocytes (CTL) followed by T-APC vaccination.

SECONDARY OBJECTIVES:

I. Evaluate the antitumor effect of adoptive T cell therapy followed by T-APC vaccination.

OUTLINE : This is a dose-escalation study of T-APC vaccine.

INFUSION I: Patients receive high-dose cyclophosphamide intravenously (IV) on days -4 and -3 and low-dose aldesleukin (IL-2) subcutaneously (SC) twice daily (BID) on days 0-14. Patients also receive CTL IV on day 0.

INFUSION II: Beginning 6-48 hours later, patients receive high-dose cyclophosphamide, low-dose IL-2, and CTL as in Infusion I. Patients also receive T-APC vaccine IV within 18-36 hours following CTL infusion and in week 4, and IL-2 SC BID on days 0-14 following second T-APC vaccination.

After completion of study treatment, patients are followed up for 8 weeks.

Conditions

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Recurrent Melanoma Stage IV Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (dose-escalation, T-APC boost, CTL)

INFUSION I: Patients receive high-dose cyclophosphamide IV on day days -4 and -3 and low-dose IL-2 SC BID on days 0-14. Patients also receive CTL IV on day 0.

INFUSION II: Beginning 6-48 hours later, patients receive high-dose cyclophosphamide, low-dose IL-2, and CTL as in Infusion I. Patients also receive T-APC vaccine IV within 18-36 hours following CTL infusion and in week 4, and IL-2 SC BID on days 0-14 following second T-APC vaccination.

Group Type EXPERIMENTAL

cyclophosphamide

Intervention Type DRUG

Given IV

aldesleukin

Intervention Type BIOLOGICAL

Given SC

autologous tumor cell vaccine

Intervention Type BIOLOGICAL

Receive T-APC via IV

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

immunologic technique

Intervention Type OTHER

Correlative studies

immunohistochemistry staining method

Intervention Type OTHER

Correlative studies

polymerase chain reaction

Intervention Type GENETIC

Correlative studies

therapeutic autologous lymphocytes

Intervention Type BIOLOGICAL

Receive adoptively transferred CD8+ antigen-specific T cell clones via IV

Interventions

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cyclophosphamide

Given IV

Intervention Type DRUG

aldesleukin

Given SC

Intervention Type BIOLOGICAL

autologous tumor cell vaccine

Receive T-APC via IV

Intervention Type BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

immunologic technique

Correlative studies

Intervention Type OTHER

immunohistochemistry staining method

Correlative studies

Intervention Type OTHER

polymerase chain reaction

Correlative studies

Intervention Type GENETIC

therapeutic autologous lymphocytes

Receive adoptively transferred CD8+ antigen-specific T cell clones via IV

Intervention Type BIOLOGICAL

Other Intervention Names

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CPM CTX Cytoxan Endoxan Endoxana IL-2 Proleukin recombinant human interleukin-2 recombinant interleukin-2 AC vaccine ATCV Autologous Cell Vaccine immunological laboratory methods laboratory methods, immunological immunohistochemistry PCR AL Autologous Lymphocytes autologous T cells

Eligibility Criteria

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Inclusion Criteria

* Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease
* Tumor expression of melanocyte differentiation antigen (MDA: MART-1 = 2+ staining or \> 25%) by immunohistochemistry (IHC)
* Expression of human leukocyte antigen (HLA)-A201
* Zubrod performance status of '0-1' at the time of treatment
* Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography \[CT\] scan)
* Normal cardiac stress test will be required for all patients with any history of cardiac disease

Exclusion Criteria

* Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry
* Serum creatinine \> 1.6 mg/dL or Creatinine clearance \< 75 ml/min
* Serum glutamic oxaloacetic transaminase (SGOT) \> 150 IU or \> 3x upper limit of normal
* Bilirubin \> 1.6 mg/dL
* Prothrombin time \> 1.5 x control
* Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in one second (FEV1) \< 2.0 L or carbon monoxide diffusing capacity (DLco) (corr for hemoglobin \[Hgb\]) \< 75% will be excluded
* Congestive heart failure
* Clinically significant hypotension
* Symptoms of coronary artery disease
* Presence of cardiac arrhythmias on electrocardiograph (EKG) requiring drug therapy
* Ejection fraction \< 50 % (echocardiogram or multi gated acquisition scan \[MUGA\])
* Symptomatic central nervous system metastases greater than 1 cm at time of therapy; patients with 1-2 asymptomatic, less than 1 cm brain/central nervous system (CNS) metastases without significant edema may be considered for treatment
* Patients with active infections or oral temperature \> 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy
* Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy; (patients with bulky disease may undergo cytoreductive chemotherapy but treatment will be discontinued at least 3 weeks prior to T cell therapy)
* Clinically significant autoimmune disorders or conditions of immunosuppression; patients with acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV)-1 associated complex or known to HIV antibody seropositive or known to be recently polymerase chain reaction (PCR)+ for hepatitis are not eligible for this study; virology testing will be done within 6 months of T cell infusion; the severely depressed immune system found in these infected patients and the possibility of premature death would compromise study objectives
* Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy
* Current treatment with steroids
* Patients must not be receiving any other experimental drugs within 3 weeks of the initiation of the protocol and must have recovered from all side effects of such therapy
* Patients for whom we are unable to generate MART-1 specific T cells

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No