Laboratory-Treated Autologous Lymphocytes and Aldesleukin After Cyclophosphamide and Fludarabine in Treating Patients With Metastatic Melanoma

NCT00863330 | Terminated Phase 2 Results DMC

• 2 other identifiers: CDR0000636885STLMC-L-0839
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Treating lymphocytes in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving laboratory-treated lymphocytes and aldesleukin together with cyclophosphamide and fludarabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well laboratory-treated autologous lymphocytes and aldesleukin work when given after cyclophosphamide and fludarabine in treating patients with metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.

  4-6 weeks after completion of TIL

Study Arms (1)

Determine toxicity of treatment regimen.

EXPERIMENTAL

Biological: Tumor Infiltrating Lymphocytes (TIL)

Interventions

Tumor Infiltrating Lymphocytes (TIL) BIOLOGICAL

Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.

Determine toxicity of treatment regimen.

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Refractory to standard treatment including high-dose aldesleukin (IL-2), unless previously ineligible for or refused IL-2 * Measurable disease with ≥ 1 lesion that is resectable for tumor-infiltrating lymphocyte generation * Patients with ≥ 1 brain metastases \< 1 cm each, or 1-2 brain metastases \> 1 cm are eligible provided they have been treated and stable for ≥ 3 months PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 3 months * ANC \> 1,000/mm\^3 (without filgrastim support) * WBC \> 3,000/mm\^3 * Hemoglobin \> 8.0 g/dL * Platelet count \> 100,000/mm\^3 * Serum ALT/AST \< 3 times upper limit of normal * Total bilirubin ≤ 2 mg/dL (\< 3 mg/dL in patients with Gilbert's syndrome) * Serum creatinine ≤ 1.6 mg/dL * LVEF \> 45% in patients meeting the following criteria: * Clinically significant atrial and/or ventricular arrhythmias, including, but not limited to, atrial fibrillation, ventricular tachycardia, or second- or third-degree heart block * At least 60 years of age * FEV\_1 \> 60% in patients meeting the following criteria: * Prolonged history of cigarette smoking * Symptoms of respiratory dysfunction * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after completion of study treatment * No HIV or hepatitis B or C positivity * No form of primary immunodeficiency (e.g., severe combined immunodeficiency disease or AIDS) * No opportunistic infections * No active systemic infections * No history of severe immediate hypersensitivity reaction to any of the agents used in this study * No coagulation disorders * No myocardial infarction, cardiac arrhythmias, or positive stress thallium or comparable test * No history of coronary revascularization or ischemic symptoms * No obstructive or restrictive pulmonary disease * No other active major medical illness of the cardiovascular, respiratory, or immune system PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy (alopecia or vitiligo allowed) * At least 6 weeks since prior ipilimumab * Must have normal colonoscopy with normal colonic biopsies * At least 4 weeks since prior systemic therapy * Minor surgical procedures within the past 3 weeks allowed provided all toxicities have recovered to ≤ grade 1 * No concurrent systemic steroids * No other concurrent experimental agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Melanoma

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

Limitations and Caveats

Study was ended early, before substantial data could be collected, due to Investigators retiring/leaving the institution.

Results Point of Contact

• Title: IIR regulatory specialist
• Organization: Aurora Health Care

jackie.blundon@aurora.org

414-219-7886

Study Officials

• John P. Hanson, MD

  St. Luke's Medical Center

  PRINCIPAL INVESTIGATOR

• Jonathan S. Treisman, MD

  St. Luke's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 3, 2024
• Results First Posted: December 17, 2014

Record last verified: 2014-12

Locations

US (1)