High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma
aldesleukin
+ sargramostim
+ cyclophosphamide
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2. * Determine the feasibility of this regimen in these patients. Secondary * Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen. * Determine time to disease progression and survival in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days 1 and 2 and fludarabine IV over 30 minutes on days 3-7. Patients then receive high-dose interleukin-2 IV every 8 hours (14 doses) on days 8-12 and 22-26. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 8 and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically confirmed melanoma * Metastatic disease * Measurable disease * No history of brain metastases * Over 18 * Karnofsky 60-100% * Life expectancy At least 12 weeks * Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL * aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome) * Hepatitis B and C negative * Creatinine ≤ 2.0 times ULN * Creatinine clearance ≥ 50 mL/min * Cardiovascular * Ejection fraction ≥ 50% * No evidence of congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * No myocardial infarction within the past 6 months * Cardiac stress test negative or of low probability for patients \> 40 years of age OR who have had prior myocardial infarction \> 6 months ago * Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age * Diffusing capacity of lung for carbon monoxide ≥ 60% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative Exclusion Criteria: * No uncontrolled diabetes * No history of autoimmune disease * No active infection * No other concurrent significant illness that would preclude study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast) * At least 4 weeks since prior immunotherapy and recovered * No other concurrent anticancer biologic agents * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent chemotherapy * At least 4 weeks since prior steroid therapy * No concurrent corticosteroids * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy * At least 4 weeks since prior surgery and recovered * No concurrent immunosuppressive therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, United StatesSee the location