Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00079144
• Date of registration: 08/03/2004
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma
• Scientific title: Treatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen
• Date of first enrolment: January 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00079144
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Steven A. Rosenberg, MD, PhD
• Affiliation: NCI - Surgery Branch

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Diagnosis of metastatic melanoma that is refractory to standard therapy (including
high-dose interleukin-2)

- Measurable disease

- HLA-A*0201 positive

- Epstein-Barr virus positive

- ESO-1-expressing disease by reverse transcription polymerase chain reaction amplified
tissue OR presence of ESO-1 serum antibody

PATIENT CHARACTERISTICS:

Age

- 16 and over

Performance status

- ECOG 0-1

Life expectancy

- More than 3 months

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 8.0 g/dL

Hepatic

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

- AST and ALT < 3 times upper limit of normal

- Bilirubin = 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)

- No coagulation disorders

Renal

- Creatinine = 2.0 mg/dL

Cardiovascular

- No prior myocardial infarction

- No major cardiovascular illness by stress thallium or comparable test

- No cardiac arrhythmias

- LVEF = 45%

- Normal cardiac stress test required for the following conditions:

- Prior EKG abnormalities

- Symptoms of cardiac ischemia

- Arrhythmias

- Age 50 and over

Pulmonary

- FEV_1 > 60% of predicted (for patients with a prolonged history of cigarette smoking
or symptoms of respiratory dysfunction)

- No obstructive or restrictive pulmonary disease

- No other major respiratory illness

Immunologic

- HIV negative

- No active systemic infection

- No opportunistic infection

- No major immune system illness

- No form of primary or secondary immunodeficiency

- No known hypersensitivity to study agents

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 4 months
after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- Prior ESO-1-based vaccination allowed

Chemotherapy

- At least 6 weeks since prior nitrosoureas and recovered

Endocrine therapy

- No concurrent systemic steroid therapy

Radiotherapy

- Recovered from prior radiotherapy

Surgery

- Not specified

Other

- At least 4 weeks since prior systemic therapy



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma (Skin)

Intervention(s)

Biological: aldesleukin

Biological: filgrastim

Biological: incomplete Freund's adjuvant

Biological: NY-ESO-1 peptide vaccine

Biological: therapeutic autologous lymphocytes

Drug: cyclophosphamide

Drug: fludarabine phosphate

Primary Outcome(s)

Clinical tumor regression [Time Frame: No]

Secondary Outcome(s)

Long-term immune status [Time Frame: No]

Survival of infused lymphocytes [Time Frame: No]

Secondary ID(s)

CDR0000354491

NCI-04-C-0104

NCI-6233

Source(s) of Monetary Support

Please refer to primary and secondary sponsors