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I am hoping to hear from June or Linda from the National Cancer Institute (NCI) regarding the clinical trials running on their campus in Bethesda, Maryland. Dr. A submitted my name and some information to them and told me to expect a call from sometime this week.

So far no phone call. I am trying not to worry about it or fixate on my phone. When my phone rings, I look for a 301 area code to show up. I am not assured a place in any clinical trial, but from what I understand I am a good candidate for participation based on my age, relative good health, and lack of complicating health issues.

One of the studies that I might be eligible for is called "Phase II Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen in Metastatic Melanoma"

This study lists the following information:

Primary Eligibility:

• Measurable metastatic melanoma with at least 1 lesion resectable for tumor-infiltrating lymphocytes (TIL) generation
• Refractory to standard treatment, including high-dose IL-2
• Patients with 1 or more brain metastasis <> 1 cm must have been treated and stable for 3 months
• ≥ 18 years of age
• ECOG 0–1
• ANC > 1,000/mm3 without filgrastim (G-CSF) support
• WBC > 3,000/mm3
• Hemoglobin > 8.0 g/dL
• Platelet count > 100,000/mm3
• HIV, hepatitis B, and hepatitis C negative
• ALT/AST <>
• Creatinine ≤ 1.6 mg/dL
• Bilirubin ≤ 2 mg/dL (patients with Gilbert’s Syndrome <>
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after completion of study treatment
• Must have recovered from prior therapy
• No concurrent systemic steroid therapy
• No form of primary immunodeficiency
• No myocardial infarction, cardiac arrhythmias, or obstructive or restrictive pulmonary disease
• No active systemic infections, coagulation disorders, or other active major illnesses
• No severe hypersensitivity to any of the agents used in the study
• No history of coronary revascularization or ischemic symptoms

Treatment Plan:

• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6, fludarabine phosphate IV over 30 minutes on Days -5 to -1, and aldesleukin IV over 15 minutes every 8 hours on Days 0–4
• Patients undergo autologous tumor-infiltrating lymphocyte infusion over 30 minutes on Day 0
• Patients also receive filgrastim (G-CSF) subcutaneously on Days 1–4 until blood counts recover
• Patients with stable disease or who have achieved a partial response or recurrence after response may receive one retreatment course beginning approximately 8 weeks after the first infusion
• Blood is collected periodically during study for research studies.

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reading this protocol, I realize that this treatment does not seem like a pleasant experience. I don't know why I was thinking that it would be any more fun than the IL-2 treatment. This treatment may or may not be in my future, and I remind myself to live in the present. On Monday, if I have not heard back from anyone at NCI, I may initiate further communication.

Labels: clinical trial, Melanoma

 Melanie wrote:
My fingers are crossed! And please let us know if there's anything we can do out here to help.

 JB aka JayBee wrote:
Thanks for the positive energy Melanie. One great comfort that I have in looking toward the possibility of spending time at the National Cancer Institute is being able to visit with friends in the DC area.

 Jamie Marie wrote:
Hi JB,

Since I work in "the business," I encourage you to follow-up this week if you have not already done so. Speaking from experience, coordinators are often inundated with calls for trials concerning disease/conditions for which there are few treatment options. It is best to be persistant without being to much so. Lots of love, Jamie

 JB aka JayBee wrote:
Jamie,

Thanks for that encouragement. I just sent an email to my contacts in Bethesda and also to my doctor.