Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and Sargramostim (GM-CSF) in Treating Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Neoplasms, Tumors, Solid Tumors, Metastatic Cancer

In brief

RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients with recurrent, refractory, or metastatic advanced solid tumors.

Key facts

Study ID: NCT01081808
Run by: Roger Williams Medical Center
People needed: 2
Starts: 2009-10-01
Expected to finish: 2015-02-01
Last updated by the study team: 2015-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed solid tumor type (ex. Head and Neck Squamous Cell Carcinoma, Colorectal, Pancreatic, Gastric, Esophageal, Renal, Prostate, Breast and Ovarian cancers, etc.); high risk, recurrent, refractory, or metastatic disease after ≥ 1 prior first-line regimen (chemotherapy or radiotherapy)
Documented EGFR-positive disease (any expression level) by immunohistochemistry (IHC)
No clinical evidence of active brain metastases; patients with brain metastases are eligible provided they have received definitive radiotherapy or chemotherapy and/or have undergone surgical resection for brain metastases
No prior hematological malignancy
Karnofsky performance status (PS) 60-100% OR RCOG PS 0-2
Life expectancy ≥ 3 months
Not pregnant or nursing
Fertile patients must use contraception
Granulocytes ≥ 1,000/mm3
Platelet count ≥ 50,000/mm3
Hemoglobin ≥ 8g/dL
BUN ≤ 2.0 times normal
Serum creatinine ≤ 2.0mg/dL
Bilirubin ≤ 1.5 times normal (with or without liver metastases)
Hepatitis B surface antigen and HIV negative
LVEF ≥ 45% at rest by MUGA
No evidence of depressed left ventricular function
No other malignancy, except for the following:
History of curatively treated in situ squamous cell carcinoma or basal cell carinoma of the skin
History of other curatively treated malignancy (except those with a hematologic origin) for with the patient has remained in complete remission > 5 years after completing therapy (as documented by history, physical exams, tumor markers, and radiology scanning)

You may not qualify if…

Serious medical or psychiatric illness that would preclude giving informed consent or receiving intensive treatment
Recent myocardial infarction (within the past year)
Current angina/coronary symptoms requiring medications
Clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA results)
Systolic blood pressure (BP) ≥ 140 mm Hg or diastolic BP ≥ 90 m Hg; patients with elevated BP must have it controlled by anti-hypertensive medications for at least 7 days prior to the infusion
Clinical evidence of active brain metastases
Prior/Concurrent Therapy
More than 4 weeks since prior chemotherapy or radiotherapy
At least 4 weeks since prior cetuximab or small molecule EGFR-inhibitors including, but not limited to, gefitinib or erlotinib hydrochloride
No concurrent radiotherapy
No concurrent steroids except for treatment or adrenal failure, septic shock, or pulmonary toxicity or hormones for non-disease-related conditions(e.g., insulin for diabetes)

Where it is running

Roger Willaims Medical Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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