Cyclophosphamide and Fludarabine Followed By an Autologous Lymphocyte Infusion and Interleukin-2 in Treating Patients With Refractory or Recurrent Metastatic Melanoma

NCT00138229 | Terminated Phase 2

• 4 other identifiers: 05019405-C-0194NCI-P6573CDR0000440165
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to remove certain immune cells may be an effective treatment for melanoma. Drugs, such as cyclophosphamide and fludarabine, may suppress the immune system so that the patient's immune cells allow the infused lymphocytes to work. Interleukin-2 may help the lymphocytes kill more tumor cells when they are put back in the body. Giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 works in treating patients with refractory or recurrent melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Tumor regression

Secondary Outcomes (2)

• Rate of repopulation of CD25-positive T-regulatory cells

• Toxicity

Interventions

aldesleukin BIOLOGICAL

filgrastim BIOLOGICAL

therapeutic autologous lymphocytes BIOLOGICAL

cyclophosphamide DRUG

fludarabine phosphate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Metastatic disease * Measurable disease * HLA-A2 negative disease * Disease did not respond to OR recurred after completion of prior high-dose interleukin-2 (IL-2) * Eligible to receive high-dose IL-2 * No tumor reactive cells available for cell transfer therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL * No coagulation disorders Hepatic * ALT and AST \< 3 times upper limit of normal * Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL if due to Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C antigen negative Renal * Creatinine ≤ 2.0 mg/dL * No renal failure requiring dialysis due to toxic effects of prior IL-2 administration Cardiovascular * No myocardial infarction * No cardiac arrhythmias * No other major cardiovascular illness as evidenced by a positive stress thallium or comparable test * Normal cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram) AND LVEF ≥ 45% (for patients ≥ 50 years of age or who have a history of EKG abnormalities, symptoms of cardiac ischemia, or arrhythmias) Pulmonary * No obstructive or restrictive pulmonary disease * No other major respiratory illness * FEV\_1 ≥ 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction) Immunologic * HIV negative * Epstein-Barr virus positive * No active systemic infection * No autoimmune disease (e.g., autoimmune colitis or Crohn's disease) * No immunodeficiency due to prior chemotherapy or radiotherapy * Recovered immune competence after prior chemotherapy or radiotherapy as evidenced by normal lymphocyte count and WBC and an absence of opportunistic infection * No other major immune system disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after completion of study treatment * No other toxic effects during prior IL-2 administration that would preclude redosing with IL-2, including the following: * Mental status changes that would require intubation * Bowel perforation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 4 weeks since prior systemic therapy Chemotherapy * At least 6 weeks since prior nitrosoureas * At least 4 weeks since prior systemic therapy Endocrine therapy * No concurrent systemic steroid therapy 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

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Surgery Branch

Bethesda, Maryland, 20892-1201, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Filgrastim; Cyclophosphamide; fludarabine phosphate

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: July 1, 2005
• Study Completion: April 1, 2007
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

US (2)